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Trial record 95 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC).

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ClinicalTrials.gov Identifier: NCT00077649
Recruitment Status : Completed
First Posted : February 13, 2004
Results First Posted : April 18, 2016
Last Update Posted : April 18, 2016
Sponsor:
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: ribavirin [Copegus]
Drug: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]
Enrollment 188
Recruitment Details A total of 188 participants were enrolled in the study which was conducted at 23 centers in the United States from 13 January 2004 to 06 December 2005
Pre-assignment Details Number of participants who completed and did not complete the 48 weeks of treatment are presented in the table .
Arm/Group Title PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
Hide Arm/Group Description Participants received 180 micrograms (mcg) of PEG-IFN [peginterferon] alfa-2a in 1 milliliter (mL) solution administered subcutaneously (SC), once weekly + 1200 milligrams (mg) of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks. Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
Period Title: Overall Study
Started 47 47 47 47
Completed 24 Weeks of Follow-up 36 40 36 31
Completed 33 38 32 30
Not Completed 14 9 15 17
Reason Not Completed
Adverse Event             5             1             7             9
Lack of Efficacy             5             3             3             2
Withdrawal by Subject             0             1             1             2
Lost to Follow-up             2             2             3             2
Abnormality of Laboratory Test             1             2             1             2
Randomized but never dosed             1             0             0             0
Arm/Group Title PEG-IFN Alfa-2a 180 mcg+ Ribavirin 1200 mg PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg Total
Hide Arm/Group Description Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks. Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks. Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks. Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks. Total of all reporting groups
Overall Number of Baseline Participants 47 47 47 47 188
Hide Baseline Analysis Population Description
The ITT [intent to treat] population which consisted of all participants who were randomized and received at least one dose of either of the study medication
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 47 participants 47 participants 47 participants 188 participants
47.2  (7.48) 49.6  (8.46) 47.1  (6.37) 48.5  (6.78) 48.1  (7.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 47 participants 47 participants 47 participants 188 participants
Female
9
  19.1%
6
  12.8%
12
  25.5%
10
  21.3%
37
  19.7%
Male
38
  80.9%
41
  87.2%
35
  74.5%
37
  78.7%
151
  80.3%
1.Primary Outcome
Title HCV RNA Profile During The First 24 Weeks
Hide Description Viral loads (quantitative HCV RNA) collected during the initial 24 weeks were first logarithmically (based 10) transformed. Results falling below the assay sensitivity level were set to the assay sensitivity level before the analyses. Thus, a qualitative HCV RNA negative result was set to 50 IU/mL (or 100 copies/mL). A qualitative HCV RNA positive result along with an unquantifiable HCV RNA result from the quantitative assay corresponded to a numeric HCV RNA result of 600 IU/mL (or 1000 copies/mL).
Time Frame Baseline (Day 1), At 72 hour (h), Week (W)-1, 2, 4, 12, 24
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.
Arm/Group Title PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
Hide Arm/Group Description:
Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
Overall Number of Participants Analyzed 46 47 47 47
Mean (Standard Deviation)
Unit of Measure: log 10 copies/mL
Baseline, (n=46,47,47,47) 6.50  (0.45) 6.61  (0.41) 6.55  (0.44) 6.53  (0.42)
At Hour 72, (n=41,41,42,46) 5.80  (0.54) 5.82  (0.84) 5.52  (0.67) 5.49  (0.90)
At Week 1, (n=44,47,45,46) 5.74  (0.58) 5.81  (0.92) 5.42  (0.84) 5.45  (0.97)
At Week 2, (n=43,45,43,46) 5.32  (0.91) 5.37  (1.20) 4.83  (1.12) 4.84  (1.27)
At Week 4, (n=44,45,44,46) 4.35  (1.32) 4.62  (1.38) 3.94  (1.36) 3.85  (1.41)
At Week 12, (n=45,45,41,44) 2.99  (1.55) 3.10  (1.53) 2.52  (1.28) 2.75  (1.57)
At Week 24, (n=42,45,40,37) 2.76  (1.59) 2.82  (1.58) 2.25  (1.10) 2.21  (1.32)
2.Primary Outcome
Title Percentage of Participants With Virological Response Over Time to Week 24
Hide Description Virological response over time to Week 24 is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, V. 2.0 (detection limit = 50 IU/mL) at 72 hours and at weeks 1, 2, 12, and 24.
Time Frame 72 hours post-dose, Weeks 1, 2, 4, 12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.
Arm/Group Title PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
Hide Arm/Group Description:
Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
Overall Number of Participants Analyzed 46 47 47 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
At Hour 72
0.0
(0.00 to 0.00)
0.0
(0.00 to 0.00)
0.0
(0.00 to 0.00)
0.0
(0.00 to 0.00)
At Week 1
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
At Week 2
0.00
(0.00 to 0.00)
2.1
(0.00 to 6.25)
2.1
(0.00 to 6.25)
2.1
(0.00 to 6.25)
At Week 4
2.2
(0.00 to 6.39)
8.5
(0.53 to 16.49)
10.6
(1.82 to 19.45)
12.8
(3.23 to 22.31)
At Week 12
47.8
(33.39 to 62.26)
38.3
(24.40 to 52.20)
53.2
(38.93 to 67.46)
51.1
(36.77 to 65.36)
At Week 24
56.5
(42.20 to 70.85)
55.3
(41.11 to 69.53)
59.6
(45.54 to 73.60)
68.1
(54.76 to 81.41)
3.Primary Outcome
Title Percentage of Participants With Predicted Sustained Virological Response
Hide Description The predicted sustained virological response (SVR) for each treatment group, is determined using a model based on the log10-transformed HCV viral load in copies/mL at Week 4 and the virological response status at Week 12. Each participant was classified as a predicted SVR if p was ≥ 0.5 or as a non-SVR if p was <0.5. The percentage was calculated from the number of participant (N) analyzed under “Distribution of the predicted probability of an SVR.”
Time Frame Week 4 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.
Arm/Group Title PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
Hide Arm/Group Description:
Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
Overall Number of Participants Analyzed 44 45 44 46
Measure Type: Number
Unit of Measure: percentage of participants
40.9 31.1 47.7 50.0
4.Secondary Outcome
Title Percentage of Participants With Sustained Virological Response
Hide Description SVR is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/ml) at the end of the 24-week untreated follow-up period.
Time Frame Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.
Arm/Group Title PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
Hide Arm/Group Description:
Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
Overall Number of Participants Analyzed 46 47 47 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
28.3
(15.25 to 41.27)
31.9
(18.59 to 45.24)
36.2
(22.43 to 49.91)
46.8
(32.54 to 61.07)
5.Secondary Outcome
Title Percentage of Participants With Virological Response at the End of the Treatment Period
Hide Description Virological response at the end of the treatment period is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/mL) at the completion of the treatment period.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.
Arm/Group Title PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
Hide Arm/Group Description:
Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
Overall Number of Participants Analyzed 46 47 47 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
45.7
(31.26 to 60.05)
57.4
(43.31 to 71.58)
55.3
(41.11 to 69.53)
55.3
(41.11 to 69.53)
6.Secondary Outcome
Title Percentage of Participants With Virological Response At 12 Weeks After The End of The Treatment Period
Hide Description Virological response at 12 weeks after the end of the treatment period is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/mL) at 12 weeks after completion of the treatment period.
Time Frame Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.
Arm/Group Title PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
Hide Arm/Group Description:
Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
Overall Number of Participants Analyzed 46 47 47 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
28.3
(15.25 to 41.27)
29.8
(16.71 to 42.86)
34.0
(20.50 to 47.59)
46.8
(32.54 to 61.07)
7.Secondary Outcome
Title Percentage of Participants With Adverse Events and Serious Adverse Events
Hide Description An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. A serious adverse event is any adverse event (SAE) that can result in death or is Life-threatening or required in-patient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Time Frame Up to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description

The safety population consisted of all participants who received at least one dose of either of the study drug and have at least one post-baseline safety assessment. Participants available at particular time point for assessment were included in the analysis.

.

Arm/Group Title PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
Hide Arm/Group Description:
Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
Overall Number of Participants Analyzed 46 47 47 47
Measure Type: Number
Unit of Measure: percentage of participants
Any AE 100 100 100 100
SAE 9 13 13 11
8.Secondary Outcome
Title Percentage of Participants With Marked Laboratory Abnormalities
Hide Description Marked laboratory abnormalities are the values outside the roche defined reference range.It is hemoglobin 11.0 – 20.0 (g/dL),platelets 100 – 700 (10^9/L), lymphocyte 1.00 – 6.30 (10^9/L),neutrophils 1.50 or more (10^9/L), white blood cells(WBC) 3.0 – 18.0 (10^9/L),serum glutamic-pyruvic transaminase (SGPT) 0 – 60 (U/L), serum glutamic oxaloacetic transaminase (SGOT) 0 – 50 (U/L), alkaline phosphatase 0 – 190 (U/L),albumin was 27.0 or more (g/L),gamma glutamyl transferases (GGT) 0 – 120 (U/L),Total protein 55 – 87 (g/L),total bilirubin 0 – 34.2 (μmol/L),BUN 0 – 14.3 (mmol/L),creatinine 0 – 154 (μmol/L),chloride 95 – 115 (mmol/L),potassium 3.0 – 6.0 (mmol/L), sodium 130 – 150 (mmol/L),thyroid stimulating hormone (TSH) 0.0 – 10.0 (mU/L),triglycerides 0.00 – 2.83 (mmol/L), calcium 2.00 – 2.90 (mmol/L),phosphate 0.75 – 1.60 (mmol/L),Blood Glucose 2.80 – 11.10 (mmol/L),Uric Acid 0 – 600 (μmol/L),proteinuria 0 – 1 (0 to 4+), glycosuria 0 – 1 (0 to 4+), hematuria 0 – 1 (0 to 4+).
Time Frame Up to Week 60
Hide Outcome Measure Data
Hide Analysis Population Description

The safety population consisted of all participants who received at least one dose of either of the study drug and have at least one post-baseline safety assessment. Participants available at particular time point for assessment where included in the analysis.

.

Arm/Group Title PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
Hide Arm/Group Description:
Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
Overall Number of Participants Analyzed 45 47 46 47
Measure Type: Number
Unit of Measure: percentage of participants
Hematocrit (fraction) Low, (n=45,47,46,47) 44 53 41 64
Hemoglobin (g/dl) - Low, (n= 45,47,46,47) 42 57 48 55
Platelets Low, (n= 45,47,46,47) 27 26 28 21
WBC – High, [n= 45,47,46,47] 0 2 0 0
WBC – Low, (n= 45,47,46,47) 76 72 70 74
Lymphocytes High, (n= 45,47,46,47) 0 0 0 2
Lymphocytes Low (n= 45,47,46,47) 73 68 72 72
Neutrophils Low, (n= 45,47,46,47) 82 79 74 74
SGPT High, (n= 45,47,46,47) 20 19 15 13
Albumin Low, (n= 45,47,46,47) 0 0 2 2
Alkaline Phosphate High, (n= 45,47,46,47) 0 0 2 0
SGOT High, (n= 45,47,46,47) 16 17 22 26
GGT High, (n= 45,47,46,47) 27 19 15 19
Total Bilirubin High, (n= 45,47,46,47) 9 6 2 2
Total Protein High, (n= 45,47,46,47) 0 0 0 4
Bun High, (n= 45,47,46,47) 0 2 0 0
Chloride High, (n= 45,47,46,47) 0 0 2 0
Chloride Low (n= 45,47,46,47) 0 2 0 2
Creatinine High, (n= 45,47,46,47) 0 2 0 0
Potassium Low, (n= 45,47,46,47) 0 2 0 0
Sodium High, (n= 45,47,46,47) 2 4 0 2
Sodium Low, (n= 45,47,46,47) 0 0 0 2
TSH High, (n= 45,46,43,46) 0 7 5 9
Calcium Low, (n= 45,47,46,47) 0 4 0 2
Phosphate High, (n= 45,47,46,47) 2 0 7 0
Phosphate Low, (n= 45,47,46,47) 31 36 20 30
Random glucose High, (n= 45,47,46,47) 2 11 4 6
Triglycerides High, (n= 45,47,46,47) 60 38 57 49
Uric acid High (n= 45,47,46,47) 9 11 2 15
Glycosuria High, (n= 44,46,44,45) 7 0 5 2
Hematuria High, (n= 44,46,44,45) 5 2 7 0
Proteinuria High, (n= 44,46,44,45) 2 2 5 0
9.Secondary Outcome
Title Percentage of Participants With Abnormal Vital Signs
Hide Description Vital signs (Systolic blood pressure, Diastolic blood pressure, Pulse rate) were considered to be abnormal and of potential clinical relevance if the values measured for these parameters represented a change from baseline of greater than 20% in the direction of worsening. High diastolic blood pressure is defined as >110 mmhg and >20% increase from baseline. High systolic blood pressure is defined as >180 mmhg and >20% increase from baseline. Low systolic blood pressure is defined as <85 mmhg and >20% decrease from baseline. High heart rate is defined as >120 beats/minute and >20% increase from baseline. Low heart rate is defined as < 50 beats/minute and >20% decrease from baseline.
Time Frame Up to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description

The safety population consisted of all participants who received at least one dose of either of the study drug and have at least one post-baseline safety assessment. Participants available at particular time point for assessment were included in the analysis.

.

Arm/Group Title PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
Hide Arm/Group Description:
Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
Overall Number of Participants Analyzed 45 47 46 47
Measure Type: Number
Unit of Measure: percentage of participants
Diastolic BP, High (n=45,47,46,47) 0 0 0 0
Systolic BP High, (n=45,47,46,47) 0 2 0 4
Systolic BP Low, (n=45,47,46,47) 0 0 2 0
Heart Rate Low, (n=45,47,46,47) 2 0 0 0
Heart Rate, High, (n=45,47,46,47) 0 0 0 0
10.Secondary Outcome
Title Total BDI-II (Beck Depression Inventory) Scores
Hide Description The BDI-II is a self-reported assessment of 21 items which included sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, loss of interest in sex that are summarized by treatment group. All except two items had four statements that were scored on a scale ranging from 0 to 3. The maximum total score was 63. The scores for each item were summed to obtain the total for that assessment. The participants neurological status could then be categorized as follows: minimal depression: 0 to 13; mild depression: 14 to 19; moderate depression: 20 to 28; and severe depression: 29 to 63. The BDI-II questionnaire was self-administered by the patient at each visit.
Time Frame From Baseline (Day 1) to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population consisted of all participants who received at least one dose of either of the study drug and have at least one post-baseline safety assessment. Participants available at particular time point for assessment were included in the analysis.
Arm/Group Title PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg PEG-IFN Alfa-2a 270 mcg+ Ribavirin 1600 mg
Hide Arm/Group Description:
Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
Overall Number of Participants Analyzed 46 47 47 47
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline, n=46,46,47,46 3.52  (4.34) 4.39  (4.82) 4.23  (4.31) 4.43  (4.70)
Week 1, (n=43,44,43,45) 4.24  (4.53) 4.45  (4.33) 4.81  (4.40) 3.96  (3.76)
Week 2, (n=43,44,43,47) 4.84  (4.51) 4.71  (5.16) 5.60  (5.31) 5.22  (5.27)
Week 4, (n=42,45,44,45) 6.31  (6.03) 5.79  (5.50) 7.21  (7.51) 6.07  (4.77)
Week 6, (n=41,41,43,44) 6.32  (6.33) 6.49  (5.40) 8.19  (7.42) 6.64  (5.71)
Week 8, (n=38,42,42,40) 6.20  (6.06) 6.24  (5.39) 8.02  (7.16) 7.69  (6.90)
Week 12, (n=44,46,42,44) 6.82  (6.93) 7.09  (5.76) 8.09  (7.19) 8.09  (8.12)
Week 18, (n=43,44,42,40) 8.04  (7.46) 8.31  (6.91) 8.62  (6.96) 8.13  (7.86)
Week 24, (n=43,45,41,37) 7.07  (7.17) 7.43  (7.04) 8.80  (7.79) 8.05  (6.37)
Week 30, (n=38,42,39,34) 8.03  (7.98) 7.89  (6.80) 9.35  (8.07) 7.74  (6.14)
Week 36, (n=36,42,37,33) 7.50  (7.13) 8.63  (8.09) 7.82  (7.48) 9.45  (8.71)
Week 42, (n=35,37,35,32) 7.49  (7.22) 8.33  (8.06) 8.00  (5.50) 8.13  (5.43)
Week 48, (n=34,40,31,29) 7.48  (7.79) 7.89  (7.79) 7.92  (5.00) 7.93  (5.13)
Week 52, (n=31,36,32,28) 4.56  (6.87) 6.62  (8.59) 4.22  (4.47) 4.21  (3.79)
Week 60, (n=34,34,31,28) 4.47  (6.18) 5.18  (6.61) 3.40  (4.08) 3.12  (4.00)
Week 72, (n=28,37,28,29) 5.00  (7.69) 5.14  (6.61) 2.92  (4.48) 2.80  (4.59)
Time Frame Up to Week 72
Adverse Event Reporting Description Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post-baseline.
 
Arm/Group Title PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
Hide Arm/Group Description Participants received 180 mcg of PEG-IFN alfa-2a in 1-ml solution administered [subcutaneously] sc, once in a week + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks Participants received 180 mcg of PEG-IFN alfa-2a in 1-ml solution administered sc once in a week + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks. Participants received 270 mcg of PEG-IFN alfa-2a in 1-ml solution administered sc once in a week + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks Participants received 270 mcg of PEG-IFN alfa-2a in 1-ml solution administered sc once in a week + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
All-Cause Mortality
PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
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 180 mcg +Ribavirin 1200 mg PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/46 (8.70%)   6/47 (12.77%)   6/47 (12.77%)   5/47 (10.64%) 
Blood and lymphatic system disorders         
Anaemia  1  1/46 (2.17%)  1/47 (2.13%)  0/47 (0.00%)  1/47 (2.13%) 
Anaemia Haemolytic Autoimmune  1  0/46 (0.00%)  1/47 (2.13%)  0/47 (0.00%)  0/47 (0.00%) 
Eye disorders         
Retinal Vascular Disorder  1  0/46 (0.00%)  0/47 (0.00%)  0/47 (0.00%)  1/47 (2.13%) 
General disorders         
Pyrexia  1  1/46 (2.17%)  0/47 (0.00%)  0/47 (0.00%)  0/47 (0.00%) 
Hepatobiliary disorders         
Cholelithiasis  1  0/46 (0.00%)  1/47 (2.13%)  0/47 (0.00%)  0/47 (0.00%) 
Immune system disorders         
Sarcoidosis  1  0/46 (0.00%)  0/47 (0.00%)  1/47 (2.13%)  0/47 (0.00%) 
Infections and infestations         
Pneumonia  1  0/46 (0.00%)  0/47 (0.00%)  2/47 (4.26%)  0/47 (0.00%) 
Bronchitis  1  0/46 (0.00%)  1/47 (2.13%)  0/47 (0.00%)  0/47 (0.00%) 
Diverticulitis  1  0/46 (0.00%)  0/47 (0.00%)  0/47 (0.00%)  1/47 (2.13%) 
Staphylococcal Sepsis  1  0/46 (0.00%)  1/47 (2.13%)  0/47 (0.00%)  0/47 (0.00%) 
Injury, poisoning and procedural complications         
Ankle Fracture  1  1/46 (2.17%)  0/47 (0.00%)  0/47 (0.00%)  0/47 (0.00%) 
Road Traffic Accident  1  0/46 (0.00%)  1/47 (2.13%)  0/47 (0.00%)  0/47 (0.00%) 
Musculoskeletal and connective tissue disorders         
Myalgia  1  0/46 (0.00%)  1/47 (2.13%)  0/47 (0.00%)  0/47 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast cancer  1  1/46 (2.17%)  0/47 (0.00%)  0/47 (0.00%)  0/47 (0.00%) 
Non Hodgkin's Lymphoma  1  0/46 (0.00%)  0/47 (0.00%)  0/47 (0.00%)  1/47 (2.13%) 
Psychiatric disorders         
Depression  1  0/46 (0.00%)  0/47 (0.00%)  1/47 (2.13%)  0/47 (0.00%) 
Homicidal Ideation  1  0/46 (0.00%)  0/47 (0.00%)  0/47 (0.00%)  1/47 (2.13%) 
Psychotic disorder  1  1/46 (2.17%)  0/47 (0.00%)  0/47 (0.00%)  0/47 (0.00%) 
Suicidal Ideation  1  0/46 (0.00%)  0/47 (0.00%)  0/47 (0.00%)  1/47 (2.13%) 
Suicide attempt  1  1/46 (2.17%)  0/47 (0.00%)  0/47 (0.00%)  0/47 (0.00%) 
Reproductive system and breast disorders         
Haemorrhagic Ovarian Cyst  1  0/46 (0.00%)  0/47 (0.00%)  1/47 (2.13%)  0/47 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Asthma  1  0/46 (0.00%)  0/47 (0.00%)  1/47 (2.13%)  0/47 (0.00%) 
Vascular disorders         
Thrombosis  1  0/46 (0.00%)  1/47 (2.13%)  0/47 (0.00%)  0/47 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (8.0)
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 180 mcg +Ribavirin 1200 mg PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   46/46 (100.00%)   46/47 (97.87%)   47/47 (100.00%)   47/47 (100.00%) 
Blood and lymphatic system disorders         
Anaemia  1  3/46 (6.52%)  6/47 (12.77%)  4/47 (8.51%)  12/47 (25.53%) 
Ear and labyrinth disorders         
Vertigio  1  0/46 (0.00%)  0/47 (0.00%)  3/47 (6.38%)  1/47 (2.13%) 
Eye disorders         
Vision blurred  1  5/46 (10.87%)  3/47 (6.38%)  5/47 (10.64%)  3/47 (6.38%) 
Gastrointestinal disorders         
Abdominal Pain  1  0/46 (0.00%)  4/47 (8.51%)  2/47 (4.26%)  3/47 (6.38%) 
Abdominal pain upper  1  4/46 (8.70%)  3/47 (6.38%)  6/47 (12.77%)  4/47 (8.51%) 
Constipation  1  3/46 (6.52%)  2/47 (4.26%)  4/47 (8.51%)  3/47 (6.38%) 
Diarrhoea  1  12/46 (26.09%)  9/47 (19.15%)  11/47 (23.40%)  10/47 (21.28%) 
Dry Mouth  1  2/46 (4.35%)  4/47 (8.51%)  6/47 (12.77%)  3/47 (6.38%) 
Dyspepsia  1  3/46 (6.52%)  4/47 (8.51%)  4/47 (8.51%)  5/47 (10.64%) 
Nausea  1  18/46 (39.13%)  20/47 (42.55%)  18/47 (38.30%)  18/47 (38.30%) 
Stomatitis  1  1/46 (2.17%)  4/47 (8.51%)  1/47 (2.13%)  1/47 (2.13%) 
Toothache  1  4/46 (8.70%)  3/47 (6.38%)  1/47 (2.13%)  4/47 (8.51%) 
Vomiting  1  6/46 (13.04%)  5/47 (10.64%)  7/47 (14.89%)  5/47 (10.64%) 
General disorders         
Asthenia  1  3/46 (6.52%)  4/47 (8.51%)  2/47 (4.26%)  5/47 (10.64%) 
Chest discomfort  1  0/46 (0.00%)  3/47 (6.38%)  0/47 (0.00%)  3/47 (6.38%) 
Chills  1  15/46 (32.61%)  14/47 (29.79%)  19/47 (40.43%)  17/47 (36.17%) 
Fatigue  1  36/46 (78.26%)  32/47 (68.09%)  35/47 (74.47%)  34/47 (72.34%) 
Injection site erythema  1  10/46 (21.74%)  9/47 (19.15%)  6/47 (12.77%)  5/47 (10.64%) 
Injection site rash  1  2/46 (4.35%)  3/47 (6.38%)  0/47 (0.00%)  1/47 (2.13%) 
Injection site reaction  1  4/46 (8.70%)  3/47 (6.38%)  2/47 (4.26%)  1/47 (2.13%) 
Irritability  1  14/46 (30.43%)  14/47 (29.79%)  12/47 (25.53%)  16/47 (34.04%) 
Malaise  1  1/46 (2.17%)  3/47 (6.38%)  5/47 (10.64%)  3/47 (6.38%) 
Pain  1  4/46 (8.70%)  1/47 (2.13%)  2/47 (4.26%)  2/47 (4.26%) 
Pyrexia  1  12/46 (26.09%)  14/47 (29.79%)  16/47 (34.04%)  14/47 (29.79%) 
Infections and infestations         
Cellulitis  1  2/46 (4.35%)  1/47 (2.13%)  4/47 (8.51%)  0/47 (0.00%) 
Herpes Simplex  1  3/46 (6.52%)  1/47 (2.13%)  2/47 (4.26%)  1/47 (2.13%) 
Oral Candidiasis  1  1/46 (2.17%)  3/47 (6.38%)  0/47 (0.00%)  0/47 (0.00%) 
Sinusitis  1  3/46 (6.52%)  2/47 (4.26%)  2/47 (4.26%)  2/47 (4.26%) 
Tooth infection  1  0/46 (0.00%)  3/47 (6.38%)  0/47 (0.00%)  0/47 (0.00%) 
Upper Respiratory tract infection  1  2/46 (4.35%)  5/47 (10.64%)  3/47 (6.38%)  6/47 (12.77%) 
Urinary tract infection  1  0/46 (0.00%)  1/47 (2.13%)  4/47 (8.51%)  0/47 (0.00%) 
Injury, poisoning and procedural complications         
Contusion  1  3/46 (6.52%)  1/47 (2.13%)  2/47 (4.26%)  1/47 (2.13%) 
Investigations         
Weight Decreased  1  6/46 (13.04%)  4/47 (8.51%)  5/47 (10.64%)  7/47 (14.89%) 
Metabolism and nutrition disorders         
Anorexia  1  6/46 (13.04%)  4/47 (8.51%)  6/47 (12.77%)  4/47 (8.51%) 
Decreased Appetite  1  5/46 (10.87%)  5/47 (10.64%)  9/47 (19.15%)  8/47 (17.02%) 
Hypertriglyceridaemia  1  2/46 (4.35%)  0/47 (0.00%)  5/47 (10.64%)  0/47 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  13/46 (28.26%)  16/47 (34.04%)  16/47 (34.04%)  15/47 (31.91%) 
Back pain  1  1/46 (2.17%)  11/47 (23.40%)  4/47 (8.51%)  3/47 (6.38%) 
Muscle spasm  1  2/46 (4.35%)  5/47 (10.64%)  3/47 (6.38%)  4/47 (8.51%) 
Myalgia  1  14/46 (30.43%)  15/47 (31.91%)  19/47 (40.43%)  16/47 (34.04%) 
Nervous system disorders         
Disturbance in attention  1  9/46 (19.57%)  4/47 (8.51%)  7/47 (14.89%)  6/47 (12.77%) 
Dizziness  1  12/46 (26.09%)  9/47 (19.15%)  7/47 (14.89%)  9/47 (19.15%) 
Dysgeusia  1  3/46 (6.52%)  0/47 (0.00%)  8/47 (17.02%)  4/47 (8.51%) 
Headache  1  24/46 (52.17%)  18/47 (38.30%)  22/47 (46.81%)  21/47 (44.68%) 
Memory impairment  1  8/46 (17.39%)  5/47 (10.64%)  3/47 (6.38%)  4/47 (8.51%) 
Tremor  1  1/46 (2.17%)  2/47 (4.26%)  4/47 (8.51%)  0/47 (0.00%) 
Psychiatric disorders         
Anger  1  3/46 (6.52%)  1/47 (2.13%)  1/47 (2.13%)  0/47 (0.00%) 
Anxiety  1  7/46 (15.22%)  3/47 (6.38%)  7/47 (14.89%)  8/47 (17.02%) 
Depression  1  14/46 (30.43%)  20/47 (42.55%)  11/47 (23.40%)  16/47 (34.04%) 
Insomnia  1  18/46 (39.13%)  20/47 (42.55%)  22/47 (46.81%)  24/47 (51.06%) 
Mood altered  1  0/46 (0.00%)  1/47 (2.13%)  4/47 (8.51%)  0/47 (0.00%) 
Sleep disorder  1  3/46 (6.52%)  3/47 (6.38%)  1/47 (2.13%)  0/47 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  9/46 (19.57%)  12/47 (25.53%)  12/47 (25.53%)  8/47 (17.02%) 
Dyspnoea  1  9/46 (19.57%)  12/47 (25.53%)  8/47 (17.02%)  12/47 (25.53%) 
Dyspnoea exertional  1  6/46 (13.04%)  1/47 (2.13%)  5/47 (10.64%)  4/47 (8.51%) 
Epistaxis  1  1/46 (2.17%)  0/47 (0.00%)  3/47 (6.38%)  1/47 (2.13%) 
Pharyngolaryngeal pain  1  3/46 (6.52%)  3/47 (6.38%)  4/47 (8.51%)  2/47 (4.26%) 
Productive Cough  1  1/46 (2.17%)  2/47 (4.26%)  3/47 (6.38%)  1/47 (2.13%) 
Respiratory tract conjestion  1  1/46 (2.17%)  2/47 (4.26%)  3/47 (6.38%)  1/47 (2.13%) 
Skin and subcutaneous tissue disorders         
Alopecia  1  4/46 (8.70%)  5/47 (10.64%)  5/47 (10.64%)  6/47 (12.77%) 
Dry Skin  1  3/46 (6.52%)  3/47 (6.38%)  4/47 (8.51%)  5/47 (10.64%) 
Hyperhidrosis  1  5/46 (10.87%)  1/47 (2.13%)  2/47 (4.26%)  8/47 (17.02%) 
Night Sweats  1  2/46 (4.35%)  1/47 (2.13%)  3/47 (6.38%)  1/47 (2.13%) 
Pruritus  1  7/46 (15.22%)  3/47 (6.38%)  6/47 (12.77%)  3/47 (6.38%) 
Rash  1  12/46 (26.09%)  11/47 (23.40%)  15/47 (31.91%)  12/47 (25.53%) 
Rash Generalised  1  2/46 (4.35%)  2/47 (4.26%)  2/47 (4.26%)  4/47 (8.51%) 
Vascular disorders         
Hypertension  1  0/46 (0.00%)  0/47 (0.00%)  1/47 (2.13%)  4/47 (8.51%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (8.0)
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: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
Phone: +41 616878333
EMail: global.trial_information@roche.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00077649     History of Changes
Other Study ID Numbers: NV17318
First Submitted: February 10, 2004
First Posted: February 13, 2004
Results First Submitted: February 3, 2016
Results First Posted: April 18, 2016
Last Update Posted: April 18, 2016