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Trial record 68 of 382 for:    IFNA2 AND RBV AND genotype

Influence of Ribavirin on the Initial Virological Response in Treatment Naïve Patients With Hepatitis C Genotype 1 Infection

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ClinicalTrials.gov Identifier: NCT02716779
Recruitment Status : Completed
First Posted : March 23, 2016
Results First Posted : July 14, 2016
Last Update Posted : August 22, 2016
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Drug: Pegylated Interferon (PEG-IFN) alfa-2a
Drug: Placebo
Drug: Ribavirin
Enrollment 68
Recruitment Details  
Pre-assignment Details Enrollment was 68: 1 participant withdrew during the screening phase and 67 participants were randomized.
Arm/Group Title Pegylated Interferon (PEG-IFN) Alfa-2a Placebo Ribavirin
Hide Arm/Group Description

Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40 kilodalton [KD]) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Ribavirin: Ribavirin, 1000 mg orally (PO) (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40 kilodalton [KD]) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40 kilodalton [KD]) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Ribavirin: Ribavirin, 1000 mg orally (PO) (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Period Title: Monotherapy
Started 14 26 27
Completed 14 25 26
Not Completed 0 1 1
Reason Not Completed
Adverse Event             0             1             1
Period Title: Combination Therapy
Started 14 25 26
Completed 14 23 25
Not Completed 0 2 1
Reason Not Completed
Adverse Event             0             2             1
Arm/Group Title Pegylated Interferon (PEG-IFN) Alfa-2a Placebo Ribavirin Total
Hide Arm/Group Description

Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Total of all reporting groups
Overall Number of Baseline Participants 14 26 27 67
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 26 participants 27 participants 67 participants
45.8  (14.4) 48.2  (15.4) 50.2  (12.9) 48.5  (14.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 26 participants 27 participants 67 participants
Female
7
  50.0%
18
  69.2%
17
  63.0%
42
  62.7%
Male
7
  50.0%
8
  30.8%
10
  37.0%
25
  37.3%
1.Primary Outcome
Title Log Likelihood Median Values of Hepatitis C-Virus (HCV) Kinetic Models for Quantitative HCV Ribonucleic Acid (RNA) Measurement With Various Assumptions of Ribavirin Mechanism of Action
Hide Description To investigate possible action mechanisms, three different models were fitted to viruskinetic data and evaluated using related log-likelihood function values. These models were designed assuming individual effects with respect to infectiousness (model 1), virus production (model 2) or degradation of infected cells rate (model 3). The following viruskinetic parameters were fitted in each model: initial viral load, loss rate of infected cells (delta), effectivity of interferon with respect to a pharmacokinetic-pharmacodynamic model. A lower log likelihood function value indicates a lesser fit for the model.
Time Frame Up to Day 126
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Hide Analysis Population Description
Per Protocol (PP) population: participants with 6 weeks of monotherapy and at least 4 weeks combination therapy as well as three quantitative HCV-RNA measurements (baseline, period 1, period 2), no major protocol violations, no treatment interruption and no dose reduction below 80% of the planned medication within the first 10 therapy weeks.
Arm/Group Title Pegylated Interferon (PEG-IFN) Alfa-2a Ribavirin Total Participant Group
Hide Arm/Group Description:

Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Combined group of PEG IFN alfa-2a, matching placebo and ribavirin arms.
Overall Number of Participants Analyzed 13 23 61
Median (95% Confidence Interval)
Unit of Measure: log likelihood function value
Model 1= infectiousness
-27.0
(-34.5 to -14.0)
-21.4
(-24.7 to -15.2)
-22.2
(-26.0 to -19.3)
Model 2= virus production
-28.2
(-35.0 to -14.3)
-23.8
(-27.5 to -21.6)
-23.9
(-27.4 to -21.6)
Model 3= degradation rate
-27.1
(-33.2 to -14.0)
-20.7
(-25.5 to -16.0)
-23.1
(-26.5 to -18.4)
2.Secondary Outcome
Title Score in Quality of Life Assessed Using Short Form-36 (SF-36) Health Questionnaire
Hide Description SF-36 is a psychometric scale to quantify health conditions. This psychometric scale has 8 dimensions of the subjective health status and consists of 36 individual items that have a varying number of related item scores (ranging from “yes/no” up to a 6-point scale). At first the raw scores were determined by summation over all items and weighted accordingly. Afterwards the raw scores were transformed to ranges of 0-100 with 100 being the highest level of health and compared to published reference scales. The following eight dimensions of subjective health conditions were considered: physical functioning index, role physical index, pain, general health perception, vitality, social functioning index, role emotional index and mental health index. The SF36 questionnaire had to be answered by the patients at screening before monotherapy, after monotherapy and at the end of the study (=end of combination therapy).
Time Frame At screening (Days -56 to -1), at end of monotherapy (Week 6) and at end of combination therapy (Week 18)
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Hide Analysis Population Description
Intent-to-treat (ITT) population includes all randomized participants who received at least one dose of study drug. Here, 'n' is the number of evaluable participants.
Arm/Group Title Pegylated Interferon (PEG-IFN) Alfa-2a Placebo Ribavirin
Hide Arm/Group Description:

Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Overall Number of Participants Analyzed 6 11 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Physical functioning index: Screening 95.6  (5.2) 76.5  (20.2) 79.7  (28.7)
Physical functioning index: End of monotherapy 90.8  (9.2) 72.3  (28.1) 68.4  (27.7)
Physical functioning index: End of comb. therapy 67.1  (20.7) 73.0  (14.0) 53.4  (31.5)
Role physical index: Screening 75.0  (41.8) 55.6  (41.0) 62.5  (40.8)
Role physical index: End of monotherapy 66.7  (34.2) 56.8  (43.4) 50.5  (40.5)
Role physical index: End of combination therapy 25.0  (38.7) 40.0  (35.7) 29.7  (40.0)
Pain: Screening 89.3  (17.0) 70.3  (26.8) 70.0  (30.8)
Pain: End of monotherapy 73.2  (23.3) 61.5  (27.4) 66.0  (29.6)
Pain: End of combination therapy 72.3  (32.2) 56.0  (11.8) 60.1  (34.8)
General health perception: Screening 58.6  (12.9) 53.6  (14.5) 62.9  (14.5)
General health perception: End of monotherapy 58.2  (7.6) 59.2  (16.9) 54.3  (18.0)
General health perception: End of comb. therapy 60.0  (14.3) 55.2  (15.0) 47.1  (20.6)
Vitality: Screening 54.2  (9.2) 52.8  (21.5) 50.9  (18.9)
Vitality: End of monotherapy 45.0  (15.2) 44.1  (16.3) 41.8  (20.1)
Vitality: End of combination therapy 40.8  (14.6) 32.5  (12.1) 39.8  (16.1)
Social functioning index: Screening 75.0  (23.7) 79.2  (24.2) 83.8  (20.6)
Social functioning index: End of monotherapy 72.9  (22.9) 68.2  (24.0) 80.1  (22.6)
Social functioning index: End of comb. therapy 68.8  (23.4) 61.3  (19.9) 56.3  (25.8)
Role emotional index: Screening 55.6  (50.2) 66.7  (50.0) 62.5  (43.7)
Role emotional index: End of monotherapy 55.6  (50.2) 69.7  (45.8) 53.3  (51.6)
Role emotional index: End of combination therapy 33.3  (51.6) 50.0  (42.3) 35.4  (39.4)
Mental health index: Screening 68.5  (9.1) 63.1  (18.1) 64.5  (15.4)
Mental health index: End of monotherapy 61.3  (12.3) 62.8  (14.0) 61.5  (19.7)
Mental health index: End of combination therapy 72.2  (9.0) 61.6  (13.2) 47.7  (23.0)
3.Secondary Outcome
Title Percentage of Participants With Treatment Response
Hide Description HCV-RNA level was measured at each visit by a central laboratory. Treatment response was estimated applying the following definitions of response/non-response: 1) Adequate first phase decline: HCV RNA decline ≥ 0.5 log10 International Units/milliliter (IU/mL) from time 0 to 48 hours of PEG-IFN treatment (PEG-IFN arm: day 0 – day 2; placebo and ribavirin arm: day 42-day 44), 2) Rapid virologic response: HCV RNA < 15 IU/mL (=detection limit) on day 70, 3) Complete early virologic response: HCV RNA < 15 IU/mL on day 126, 4) Partial early virologic response (log decrease): HCV RNA decrease ≥ 2 log10 IU/mL from day 0 to day 126, 5) Partial early virologic response (cut off): HCV RNA <30000 IU/mL on day 126, 6) Non-response: HCV RNA decrease <2 log10 IU/mL from day 0 to day 126, 7) Null-response: HCV RNA decrease <1 log10 IU/mL from day 0 to day 28 and from day 0 to day 70 for PEG-IFN arm and placebo / ribavirin arm, respectively.
Time Frame Up to Day 126
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable participants of the Intent-to-Treat (ITT) population, who were documented for a total of 126 days of the treatment period.
Arm/Group Title Pegylated Interferon (PEG-IFN) Alfa-2a Placebo Ribavirin
Hide Arm/Group Description:

Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Overall Number of Participants Analyzed 14 23 25
Measure Type: Number
Unit of Measure: percentage of participants
Adequate first phase decline 79 65 72
Rapid virologic response 43 30 20
Complete early virologic response 64 48 72
Partial early virologic response (log decrease) 79 78 84
Partial early virologic response (cut off) 79 78 84
Non-response 21 22 16
Null responder 36 26 12
4.Secondary Outcome
Title Area Under the Concentration-Time Curve (AUC) of Ribavirin
Hide Description Evaluation of ribavirin arm after Day 0. Evaluation of placebo and PEG-IFN arms after Day 42.
Time Frame From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.
Arm/Group Title Pegylated Interferon (PEG-IFN) Alfa-2a Placebo Ribavirin
Hide Arm/Group Description:

Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Overall Number of Participants Analyzed 13 23 25
Median (95% Confidence Interval)
Unit of Measure: (microgram/milliliter)*day ([mcg/ml]*d)
186.6
(142.3 to 201.4)
179.4
(142.6 to 203.8)
290.1
(257.6 to 370.5)
5.Secondary Outcome
Title Maximum Concentration (Cmax) of Ribavirin
Hide Description Cmax was obtained directly from the concentration-time data. Evaluation of ribavirin arm after day 0. Evaluation of placebo and PEG-IFN arms after day 42.
Time Frame From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.
Arm/Group Title Pegylated Interferon (PEG-IFN) Alfa-2a Placebo Ribavirin
Hide Arm/Group Description:

Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Overall Number of Participants Analyzed 13 23 25
Median (95% Confidence Interval)
Unit of Measure: mcg/ml
2.95
(2.79 to 3.60)
2.83
(2.34 to 3.26)
3.37
(2.93 to 4.19)
6.Secondary Outcome
Title Time to Maximum Concentration (Tmax) of Ribavirin
Hide Description Tmax was obtained directly from the concentration-time data. Evaluation of ribavirin arm after day 0. Evaluation of placebo and PEG-IFN arms after day 42.
Time Frame From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.
Arm/Group Title Pegylated Interferon (PEG-IFN) Alfa-2a Placebo Ribavirin
Hide Arm/Group Description:

Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Overall Number of Participants Analyzed 13 23 25
Median (95% Confidence Interval)
Unit of Measure: weeks
6.0
(4.0 to 12.0)
8.0
(6.0 to 12.0)
6.4
(6.1 to 8.0)
7.Secondary Outcome
Title Area Under the Concentration-Time Curve (AUC) of PEG-IFN
Time Frame From Day 0 at 0 hour (hr), 24 hr, 48 hr and 72 hr, Day 42 at 0 hr and 24 hr and at approximately every other visit up to Day 126
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.
Arm/Group Title Pegylated Interferon (PEG-IFN) Alfa-2a Placebo Ribavirin
Hide Arm/Group Description:

Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Overall Number of Participants Analyzed 14 22 25
Median (95% Confidence Interval)
Unit of Measure: (nanogram/milliliter)*day ([ng/ml]*d)
2097.9
(1763.5 to 2997.3)
1270.4
(931.8 to 1572.0)
1164.9
(925.2 to 1461.3)
8.Secondary Outcome
Title Maximum Concentration (Cmax) of PEG-IFN
Hide Description Cmax was obtained directly from the concentration-time data. Evaluation of PEG-IFN arm after day 0. Evaluation of ribavirin and placebo arms after day 42.
Time Frame From Day 0 at 0 hour (hr), 24 hr, 48 hr and 72 hr, Day 42 at 0 hr and 24 hr and at approximately every other visit up to Day 126
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.
Arm/Group Title Pegylated Interferon (PEG-IFN) Alfa-2a Placebo Ribavirin
Hide Arm/Group Description:

Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Overall Number of Participants Analyzed 14 22 25
Median (95% Confidence Interval)
Unit of Measure: ng/ml
28.77
(22.80 to 32.38)
20.36
(16.92 to 25.83)
19.8
(15.80 to 22.30)
9.Secondary Outcome
Title Time to Maximum Concentration (Tmax) of PEG-IFN
Hide Description Tmax was obtained directly from the concentration-time data. Evaluation of PEG-IFN arm after day 0. Evaluation of ribavirin and placebo arms after day 42.
Time Frame From Day 0 at 0 hour (hr), 24 hr, 48 hr and 72 hr, Day 42 at 0 hr and 24 hr and at approximately every other visit up to Day 126
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.
Arm/Group Title Pegylated Interferon (PEG-IFN) Alfa-2a Placebo Ribavirin
Hide Arm/Group Description:

Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Overall Number of Participants Analyzed 14 22 25
Median (95% Confidence Interval)
Unit of Measure: weeks
6.3
(6.1 to 8.0)
12.0
(6.0 to 12.0)
6.0
(6.0 to 12.0)
10.Secondary Outcome
Title Area Under the Concentration-Time Curve (AUC) of Glutamate-Pyruvate Transaminase (GPT)
Hide Description [Not Specified]
Time Frame From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.
Arm/Group Title Pegylated Interferon (PEG-IFN) Alfa-2a Placebo Ribavirin
Hide Arm/Group Description:

Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Overall Number of Participants Analyzed 14 23 25
Median (95% Confidence Interval)
Unit of Measure: (Units/liter)*day ([U/L]*d)
5078.3
(4358.3 to 6576.5)
7233.5
(5337.3 to 8656.3)
5231.3
(3917.0 to 5852.5)
11.Secondary Outcome
Title Maximum Concentration (Cmax) of GPT
Hide Description Cmax was obtained directly from the concentration-time data.
Time Frame From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.
Arm/Group Title Pegylated Interferon (PEG-IFN) Alfa-2a Placebo Ribavirin
Hide Arm/Group Description:

Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Overall Number of Participants Analyzed 14 23 25
Median (95% Confidence Interval)
Unit of Measure: U/L
68.5
(59.0 to 112.0)
88.0
(67.0 to 123.0)
75.0
(56.0 to 110.0)
12.Secondary Outcome
Title Time to Maximum Concentration (Tmax) of GPT
Hide Description Tmax was obtained directly from the concentration-time data.
Time Frame From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.
Arm/Group Title Pegylated Interferon (PEG-IFN) Alfa-2a Placebo Ribavirin
Hide Arm/Group Description:

Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Overall Number of Participants Analyzed 14 23 25
Median (95% Confidence Interval)
Unit of Measure: days
2.8
(2.0 to 28.0)
14.0
(10.0 to 42.5)
3.0
(2.0 to 7.0)
Time Frame Up to Day 126
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PEG-IFN Alfa-2a, Period 1 Monotherapy Placebo, Period 1 Monotherapy Ribavirin, Period 1 Monotherapy PEG-IFN Alfa-2a, Period 2 Combination Therapy Placebo, Period 2 Combination Therapy Ribavirin, Period 2 Combination Therapy
Hide Arm/Group Description

Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks in period 1.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks.

Participants with chronic hepatitis C, genotype 1, received placebo PO for 6 weeks in period 1.

Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.

Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks in period 1.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks.

In period 2 participants, who received PEG-IFN monotherapy in period 1, received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks.

In period 2 participants, who received placebo in period 1, received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks.

In period 2 participants, who received ribavirin monotherapy in period 1, received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.

Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks.

Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks.

All-Cause Mortality
PEG-IFN Alfa-2a, Period 1 Monotherapy Placebo, Period 1 Monotherapy Ribavirin, Period 1 Monotherapy PEG-IFN Alfa-2a, Period 2 Combination Therapy Placebo, Period 2 Combination Therapy Ribavirin, Period 2 Combination Therapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PEG-IFN Alfa-2a, Period 1 Monotherapy Placebo, Period 1 Monotherapy Ribavirin, Period 1 Monotherapy PEG-IFN Alfa-2a, Period 2 Combination Therapy Placebo, Period 2 Combination Therapy Ribavirin, Period 2 Combination Therapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   1/26 (3.85%)   0/27 (0.00%)   0/14 (0.00%)   2/25 (8.00%)   2/26 (7.69%) 
Eye disorders             
Retinal haemorrhage  1  0/14 (0.00%)  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  1/25 (4.00%)  0/26 (0.00%) 
Infections and infestations             
Otitis media  1  0/14 (0.00%)  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/25 (0.00%)  1/26 (3.85%) 
Urinary tract infection  1  0/14 (0.00%)  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/25 (0.00%)  1/26 (3.85%) 
Psychiatric disorders             
Depression  1  0/14 (0.00%)  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  1/25 (4.00%)  0/26 (0.00%) 
Surgical and medical procedures             
Psychotherapy  1  0/14 (0.00%)  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/25 (0.00%)  1/26 (3.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PEG-IFN Alfa-2a, Period 1 Monotherapy Placebo, Period 1 Monotherapy Ribavirin, Period 1 Monotherapy PEG-IFN Alfa-2a, Period 2 Combination Therapy Placebo, Period 2 Combination Therapy Ribavirin, Period 2 Combination Therapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/14 (64.29%)   9/26 (34.62%)   12/27 (44.44%)   12/14 (85.71%)   23/25 (92.00%)   24/26 (92.31%) 
Blood and lymphatic system disorders             
Leukopenia  1  1/14 (7.14%)  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/25 (0.00%)  0/26 (0.00%) 
Neutropenia  1  1/14 (7.14%)  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/25 (0.00%)  0/26 (0.00%) 
Anaemia  1  0/14 (0.00%)  0/26 (0.00%)  0/27 (0.00%)  1/14 (7.14%)  2/25 (8.00%)  1/26 (3.85%) 
Thrombocytopenia  1  0/14 (0.00%)  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/25 (0.00%)  2/26 (7.69%) 
Iron deficiency anaemia  1  0/14 (0.00%)  0/26 (0.00%)  0/27 (0.00%)  1/14 (7.14%)  0/25 (0.00%)  0/26 (0.00%) 
Eye disorders             
Keratoconjunctivitis sicca  1  1/14 (7.14%)  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/25 (0.00%)  0/26 (0.00%) 
Vision blurred  1  1/14 (7.14%)  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/25 (0.00%)  0/26 (0.00%) 
Gastrointestinal disorders             
Nausea  1  2/14 (14.29%)  2/26 (7.69%)  1/27 (3.70%)  4/14 (28.57%)  8/25 (32.00%)  5/26 (19.23%) 
Diarrhoea  1  1/14 (7.14%)  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  5/25 (20.00%)  1/26 (3.85%) 
Abdominal pain lower  1  1/14 (7.14%)  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/25 (0.00%)  0/26 (0.00%) 
Abdominal pain upper  1  1/14 (7.14%)  0/26 (0.00%)  0/27 (0.00%)  1/14 (7.14%)  1/25 (4.00%)  1/26 (3.85%) 
Toothache  1  1/14 (7.14%)  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/25 (0.00%)  0/26 (0.00%) 
Dry mouth  1  0/14 (0.00%)  0/26 (0.00%)  0/27 (0.00%)  1/14 (7.14%)  1/25 (4.00%)  1/26 (3.85%) 
Constipation  1  0/14 (0.00%)  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  2/25 (8.00%)  0/26 (0.00%) 
General disorders             
Fatigue  1  3/14 (21.43%)  1/26 (3.85%)  4/27 (14.81%)  0/14 (0.00%)  9/25 (36.00%)  6/26 (23.08%) 
Chills  1  2/14 (14.29%)  1/26 (3.85%)  0/27 (0.00%)  0/14 (0.00%)  3/25 (12.00%)  1/26 (3.85%) 
Influenza like illness  1  3/14 (21.43%)  0/26 (0.00%)  0/27 (0.00%)  1/14 (7.14%)  5/25 (20.00%)  9/26 (34.62%) 
Asthenia  1  0/14 (0.00%)  0/26 (0.00%)  2/27 (7.41%)  0/14 (0.00%)  0/25 (0.00%)  0/26 (0.00%) 
Pyrexia  1  1/14 (7.14%)  0/26 (0.00%)  0/27 (0.00%)  1/14 (7.14%)  3/25 (12.00%)  3/26 (11.54%) 
Infections and infestations             
Nasopharyngitis  1  0/14 (0.00%)  2/26 (7.69%)  0/27 (0.00%)  0/14 (0.00%)  0/25 (0.00%)  0/26 (0.00%) 
Cystitis  1  0/14 (0.00%)  0/26 (0.00%)  0/27 (0.00%)  1/14 (7.14%)  0/25 (0.00%)  0/26 (0.00%) 
Ear infection  1  0/14 (0.00%)  0/26 (0.00%)  0/27 (0.00%)  1/14 (7.14%)  0/25 (0.00%)  0/26 (0.00%) 
Pharyngitis  1  0/14 (0.00%)  0/26 (0.00%)  0/27 (0.00%)  1/14 (7.14%)  0/25 (0.00%)  0/26 (0.00%) 
Metabolism and nutrition disorders             
Decreased appetite  1  1/14 (7.14%)  0/26 (0.00%)  1/27 (3.70%)  0/14 (0.00%)  4/25 (16.00%)  3/26 (11.54%) 
Musculoskeletal and connective tissue disorders             
Muscle spasms  1  0/14 (0.00%)  2/26 (7.69%)  1/27 (3.70%)  0/14 (0.00%)  0/25 (0.00%)  0/26 (0.00%) 
Pain in extremity  1  2/14 (14.29%)  0/26 (0.00%)  1/27 (3.70%)  2/14 (14.29%)  2/25 (8.00%)  4/26 (15.38%) 
Bone pain  1  1/14 (7.14%)  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/25 (0.00%)  0/26 (0.00%) 
Arthralgia  1  0/14 (0.00%)  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  5/25 (20.00%)  2/26 (7.69%) 
Back pain  1  0/14 (0.00%)  0/26 (0.00%)  0/27 (0.00%)  1/14 (7.14%)  3/25 (12.00%)  2/26 (7.69%) 
Myalgia  1  0/14 (0.00%)  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  2/25 (8.00%)  1/26 (3.85%) 
Nervous system disorders             
Headache  1  2/14 (14.29%)  4/26 (15.38%)  4/27 (14.81%)  2/14 (14.29%)  10/25 (40.00%)  5/26 (19.23%) 
Dizziness  1  0/14 (0.00%)  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  2/25 (8.00%)  5/26 (19.23%) 
Disturbance in attention  1  0/14 (0.00%)  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  1/25 (4.00%)  2/26 (7.69%) 
Psychiatric disorders             
Sleep disorder  1  0/14 (0.00%)  1/26 (3.85%)  2/27 (7.41%)  0/14 (0.00%)  4/25 (16.00%)  2/26 (7.69%) 
Mood swings  1  0/14 (0.00%)  0/26 (0.00%)  0/27 (0.00%)  1/14 (7.14%)  2/25 (8.00%)  1/26 (3.85%) 
Depression  1  0/14 (0.00%)  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  2/25 (8.00%)  0/26 (0.00%) 
Initial insomnia  1  0/14 (0.00%)  0/26 (0.00%)  0/27 (0.00%)  1/14 (7.14%)  0/25 (0.00%)  0/26 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Dyspnoea exertional  1  1/14 (7.14%)  0/26 (0.00%)  1/27 (3.70%)  1/14 (7.14%)  1/25 (4.00%)  0/26 (0.00%) 
Cough  1  0/14 (0.00%)  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  1/25 (4.00%)  4/26 (15.38%) 
Skin and subcutaneous tissue disorders             
Dry skin  1  1/14 (7.14%)  0/26 (0.00%)  0/27 (0.00%)  1/14 (7.14%)  2/25 (8.00%)  0/26 (0.00%) 
Night sweats  1  1/14 (7.14%)  0/26 (0.00%)  0/27 (0.00%)  0/14 (0.00%)  0/25 (0.00%)  0/26 (0.00%) 
Pruritus  1  0/14 (0.00%)  0/26 (0.00%)  0/27 (0.00%)  1/14 (7.14%)  5/25 (20.00%)  4/26 (15.38%) 
Rash  1  0/14 (0.00%)  0/26 (0.00%)  0/27 (0.00%)  2/14 (14.29%)  2/25 (8.00%)  4/26 (15.38%) 
Urticaria  1  0/14 (0.00%)  0/26 (0.00%)  0/27 (0.00%)  1/14 (7.14%)  0/25 (0.00%)  0/26 (0.00%) 
Vascular disorders             
Hypertension  1  0/14 (0.00%)  0/26 (0.00%)  0/27 (0.00%)  1/14 (7.14%)  0/25 (0.00%)  1/26 (3.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02716779     History of Changes
Other Study ID Numbers: ML19301
2006-000935-86 ( EudraCT Number )
First Submitted: March 18, 2016
First Posted: March 23, 2016
Results First Submitted: June 6, 2016
Results First Posted: July 14, 2016
Last Update Posted: August 22, 2016