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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Ribavirin in Patients With Chronic Hepatitis C (CHC) Previously Treated With PEG-Intron + Ribavirin

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ClinicalTrials.gov Identifier: NCT00087568
Recruitment Status : Completed
First Posted : July 14, 2004
Results First Posted : June 8, 2016
Last Update Posted : June 8, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Drug: Ribavirin
Drug: peginterferon alfa-2a [Pegasys]
Enrollment 57
Recruitment Details This study was conducted from 29 Jan 2003 to 24 Mar 2006 across 14 centers in the United States.
Pre-assignment Details A total of 80 participants (40 non-tolerators and 40 non-responders) were planned; however, 57 participants were enrolled only after receiving 12 weeks of PEG-Intron plus ribavirin therapy and received the study medication (25 non-tolerators and 32 non-responders).
Arm/Group Title Non-Responders Non-Tolerators
Hide Arm/Group Description Participants received Pegasys 180 micrograms (µg) subcutaneously (SC) once a week and ribavirin 1000 or 1200 milligrams per day [mg/day (< or >=75 kg body weight, respectively)], orally in divided doses for 60 weeks. Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
Period Title: Overall Study
Started 32 25
Completed 2 23
Not Completed 30 2
Reason Not Completed
Adverse Event             4             0
Withdrawal by Subject             1             1
Lost to Follow-up             1             0
Lack of Efficacy             24             1
Arm/Group Title Non-Responders Non-Tolerators Total
Hide Arm/Group Description Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks. Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks. Total of all reporting groups
Overall Number of Baseline Participants 32 25 57
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) Population included all enrolled participants who received at least one dose of study medication (Pegasys or ribavirin).
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 32 participants 25 participants 57 participants
47.0
(32 to 68)
49.0
(35 to 66)
49.0
(32 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 25 participants 57 participants
Female
15
  46.9%
7
  28.0%
22
  38.6%
Male
17
  53.1%
18
  72.0%
35
  61.4%
1.Primary Outcome
Title Number of Pegasys and Ribavirin Therapy Completers
Hide Description Therapy completers were defined as all participants who had demonstrable viremia after 12 weeks of Pegasys plus ribavirin therapy (who were to be discontinued for lack of efficacy), non-tolerators who completed 36 weeks of Pegasys plus ribavirin therapy, and non-responders who completed 60 weeks of Pegasys plus ribavirin therapy. Study completers included all participants who completed the planned treatment period (36 weeks for non-tolerators and 60 weeks for non-responders) and the 24-week treatment-free follow-up period and participants in either group who were prematurely discontinued per protocol due to insufficient therapeutic response at Week 12.
Time Frame 36 weeks for Non-Tolerators and 60 weeks for Non-Responders
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all enrolled participants who received at least one dose of study medication (Pegasys or ribavirin) and had at least one post-baseline safety assessment which defined as clinical adverse event, laboratory or vital sign data, physical examination finding, Beck Depression Inventory (BDI-II), or Fatigue severity score (FSS).
Arm/Group Title Non-Responders Non-Tolerators
Hide Arm/Group Description:
Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
Overall Number of Participants Analyzed 32 25
Measure Type: Number
Unit of Measure: Participants
Completing 36 weeks 3 23
Completing 60 weeks 2 23
2.Secondary Outcome
Title Number of Participants With >=2-log10 Decrease or Undetectable (<60 International Units Per Milliliter) Hepatitis C Virus-ribonucleic Acid Over Time
Hide Description Sustained virological response (SVR) is defined as undetectable Hepatitis C virus-ribonucleic acid (HCV RNA)(<60 International units per milliliter) or HCV RNA for >=2-log10 decrease in viral titre, 24 weeks after the end of treatment. A participant was classified as non-responder (SVR not achieved) if HCV RNA was detectable at the completion of antiviral treatment, at Week 24 post or at any time between Week 24 and completion of antiviral treatment. HCV RNA measured prior to or on the date of the first dose of Pegasys plus ribavirin was used as the baseline in all HCV RNA analyses.
Time Frame Weeks 4, 12, 24, 36, 48, 60, and 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) Population included all enrolled participants who received at least one dose of study medication (Pegasys or ribavirin).
Arm/Group Title Non-Responders Non-Tolerators
Hide Arm/Group Description:
Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
Overall Number of Participants Analyzed 32 25
Measure Type: Number
Unit of Measure: Participants
Week 4 1 16
Week 12 4 24
Week 24 1 21
Week 36 2 21
Week 48 1 11
Week 60 2 14
Week 84 1 0
3.Secondary Outcome
Title Number of Participants With Normal Serum Alanine Transaminase Levels Over Time
Hide Description The number of participants with serum alanine transaminase (ALT) concentration within the normal range at each time point assessed. Upper limit of normal serum ALT for men is 43 International units per liter (IU/L) and for women is 34 IU/L.
Time Frame Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, and 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all enrolled participants who received at least one dose of study medication (Pegasys or ribavirin).
Arm/Group Title Non-Responders Non-Tolerators
Hide Arm/Group Description:
Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
Overall Number of Participants Analyzed 32 25
Measure Type: Number
Unit of Measure: Participants
Baseline 21 21
Week 4 18 19
Week 12 9 19
Week 24 6 16
Week 36 3 15
Week 48 3 14
Week 60 1 15
Week 84 1 0
4.Secondary Outcome
Title Number of Participants With Serious Adverse Events and Adverse Events
Hide Description An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An adverse event could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions that worsened during the study were also to be reported as adverse events. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, 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 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all enrolled participants who received at least one dose of study medication (Pegasys or ribavirin) and had at least one post-baseline safety assessment (defined as clinical adverse event, laboratory or vital sign data, physical examination finding, BDI-II score, or FSS score).
Arm/Group Title Non-Responders Non-Tolerators
Hide Arm/Group Description:
Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
Overall Number of Participants Analyzed 32 25
Measure Type: Number
Unit of Measure: Participants
any SAE 1 1
any AE 29 23
5.Secondary Outcome
Title Mean Score of Beck Depression Inventory Over Time
Hide Description The Beck Depression Inventory (BDI-II) is a questionnaire with groups of statements in which the patient is asked to select the statement that most clearly describes the way he/she has felt in the past two weeks, including today. The score for each group is tallied and the ranges of scores are used as guidelines for measuring the degree of depression. For this study, scores are defined as follows: 0 to 15 as minimal, 16 to 21 as mild, 22 to 30 as moderate, and 31 to 63 as severe. The questionnaire was in two areas (changes in sleeping pattern and changes in appetite), selections 1, 2, and 3 contained options for both more and less with respect to the area of interest. Four statements (labelled 0, 1, 2, and 3) were offered that described the area of interest, with 0 indicating no effect and 3 indicating the worst effect. The individual area scores were summed to provide a total score.
Time Frame Baseline (Week 0); Weeks 4, 12, 24, 36, 48, 60, and 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all enrolled participants who received at least one dose of study drug and had at least one post-baseline safety assessment (a clinical adverse event, laboratory or vital sign data, physical examination finding, BDI-II score, or FSS score). n = number of participants available at the particular time for assessment.
Arm/Group Title Non-Responders Non-Tolerators
Hide Arm/Group Description:
Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
Overall Number of Participants Analyzed 32 25
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline, (n = 32, 25) 10.93  (9.32) 15.03  (7.56)
Week 4, (n = 31, 24) 9.52  (8.34) 10.68  (5.64)
Week 12, (n = 27, 24) 8.63  (7.74) 10.76  (7.97)
Week 24, (n = 2, 23) 3.75  (0.64) 11.26  (7.30)
Week 36, (n = 3, 19) 5.40  (3.83) 8.65  (5.73)
Week 48, (n = 2, 21) 6.15  (4.03) 4.30  (4.54)
Week 60, (n = 2, 21) 3.00  (4.24) 3.62  (3.40)
Week 84, (n = 2, 0) 1.50  (2.12) NA [1]   (NA)
[1]
No participants in the "Non-Tolerators" provided data at Week 84
6.Secondary Outcome
Title Mean Score of Fatigue Severity Over Time
Hide Description The Fatigue severity score (FSS) scale has a series of questions designed to assess tiredness, lack of energy, or total body give-out. Participants were to react to nine statements regarding fatigue over the previous 2 weeks, each on a scale (1 = completely agree, 7 = completely disagree). The FSS is the average of the scores on the 9 questions; ranging from 1-7, with lower scores indicating less fatigue. In addition, participants were to react to how much fatigue they had in the past 2 or 4 weeks by marking on a visual analogue scale labelled at one end with “no fatigue” (‘0’ being the best) and at the other end with “greater fatigue” (‘100’ being the worst). Longer distance on the scale from “no fatigue” indicated “greater fatigue”. FSS values are presented based on questionnaire and visual analog scale.
Time Frame Baseline (Week 0); Weeks 4, 12, 24, 36, 48, 60, and 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all the enrolled participants who received at least one dose of study medication and had at least one post-baseline safety assessment (a clinical adverse event, laboratory or vital sign data, physical examination finding, or FSS score). n = number of participants available at the particular time for assessment.
Arm/Group Title Non-Responders Non-Tolerators
Hide Arm/Group Description:
Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
Overall Number of Participants Analyzed 32 25
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Total FSS, Baseline, (n = 32, 25) 4.66  (1.73) 5.14  (1.27)
Total FSS, Week 4, (n = 31, 24) 4.27  (1.76) 4.50  (1.59)
Total FSS, Week 12, (n = 27, 24) 4.09  (1.84) 4.72  (1.72)
Total FSS, Week 24, (n = 2, 23) 1.33  (0.47) 4.99  (1.56)
Total FSS, Week 36,(n = 3, 19) 2.52  (1.41) 4.62  (1.75)
Total FSS, Week 48, (n = 2, 21) 2.22  (1.73) 3.17  (1.17)
Total FSS, Week 60, (n = 2, 20) 2.44  (2.04) 2.97  (1.13)
Total FSS, Week 84, (n = 2, 0) 1.61  (0.86) NA [1]   (NA)
Visual analog based FSS, Baseline, (n = 32, 25) 48.72  (25.64) 61.92  (23.38)
Visual analog based FSS, Week 4, (n = 31, 24) 47.87  (29.67) 52.08  (25.92)
Visual analog based FSS, Week 12, (n = 27, 24) 52.15  (31.52) 55.00  (26.96)
Visual analog based FSS, Week 24, (n = 2, 23) 54.50  (19.09) 56.52  (28.70)
Visual analog based FSS, Week 36, (n = 3, 19) 47.33  (16.65) 48.79  (29.09)
Visual analog based FSS, Week 48, (n = 2, 21) 26.00  (1.41) 25.24  (22.27)
Visual analog based FSS, Week 60, (n = 2, 20 31.00  (2.83) 31.55  (32.45)
Visual analog based FSS, Week 84, (n = 2, 0) 21.50  (16.26) NA [1]   (NA)
[1]
No participants in the "Non-Tolerators" provided data at Week 84
7.Secondary Outcome
Title Number of Participants With Individual Flu-like Symptom
Hide Description Participants were asked to complete a flu-like symptom questionnaire at screening, study baseline, and at all subsequent scheduled visits. The “yes/no” questionnaire evaluated the incidence of headache, fever, myalgia, and chills. If a participant answered “yes” to the question “Has the patient experienced any flu-like symptoms since the last visit?” all among headache, fever, muscle aches (myalgia), and chills that applied were to be marked. If any of the experienced symptoms was newly reported or had worsened, a corresponding adverse event was to be reported.
Time Frame Baseline (Week 0); Weeks 12, 36, 60 and 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all the enrolled participants who received at least one dose of study medication and had at least one post-baseline safety assessment (a clinical adverse event, laboratory or vital sign data, physical examination data, BDI-II score, or FSS score). n = number of participants available at the particular time of assessment.
Arm/Group Title Non-Responders Non-Tolerators
Hide Arm/Group Description:
Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
Overall Number of Participants Analyzed 32 25
Measure Type: Number
Unit of Measure: Participants
Baseline, Headache, (n = 32, 25) 16 19
Baseline, Fever, (n = 32, 25) 10 14
Baseline, Muscle aches, (n = 32, 25) 17 21
Baseline, Chills, (n = 32, 25) 12 17
Week 12, Headache, (n = 27, 24) 13 13
Week 12, Fever, (n = 27, 24) 3 5
Week 12, Muscle aches, (n = 27, 24) 8 10
Week 12, Chills, (n = 27, 24) 2 5
Week 36, Headache, (n = 3, 19) 2 10
Week 36, Fever, (n = 3, 19) 1 3
Week 36, Muscle aches, (n = 3, 19) 1 8
Week 36, Chills, (n = 3, 19) 1 7
Week 60, Headache, (n = 2, 22) 0 1
Week 60, Fever, (n = 2, 22) 0 0
Week 60, Muscle aches, (n = 2, 22) 0 2
Week 60, Chills, (n = 2, 22) 0 1
Week 84, Headache, (n = 32, 25) 19 18
Week 84, Fever, (n = 32, 25) 10 14
Week 84, Muscle aches, (n = 32, 25) 18 19
Week 84, Chills, (n = 32, 25) 9 15
8.Secondary Outcome
Title Number of Participants With Marked Laboratory Abnormalities
Hide Description Analysis was performed for hematology, clinical chemistry, thyroid function, and urinalysis. Normal ranges of the parameters were: Haematocrit (fraction): 0.37 - 0.49, Haemoglobin (g/L): 130 - 180 , Platelets (G/L): 150 - 350, White blood cell (G/L): 4.5 - 11.0, Lymphocytes (G/L): 1.00 - 4.80, Neutrophils (G/L): 1.80 - 7.70, Prothrombin Time in Seconds (sec): not defined, Prothrombin Time, normalized (ratio): 0.70 - 1.30, Partial thromboplastin Time (sec): 22.1 - 34.1, Aspartate transaminase (AST) or serum glutamate oxaloacetate transaminase (SGOT) in IU/L: 0 - 40, Alkaline Phosphatase (IU/L): 0 - 115, ALT or serum glutamate pyruvate transaminase (SGPT) in (IU/L): 0-55, Total Bilirubin (umol/L): 0 -17, Thyroxine (T4) (nmol/L): 58 -140, Thyroid-stimulating hormone (TSH, [U/mL]): 0.0 - 5.0, Triglycerides (mmol/L): 0.45 - 1.69, Phosphate (mmol/L): 0.84 - 1.45, Uric Acid (umol/L): 214 - 506
Time Frame Up to Week 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all the enrolled participants who received at least one dose of study medication and had at least one post-baseline safety assessment (a clinical adverse event, laboratory, vital sign, or physical examination finding, BDI-II score, or FSS score). 'n' = number of participants available at the time of assessment.
Arm/Group Title Non-Responders Non-Tolerators
Hide Arm/Group Description:
Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
Overall Number of Participants Analyzed 32 25
Measure Type: Number
Unit of Measure: participants
Hematocrit (fraction) - Low (n = 32, 25) 5 3
Hemoglobin-Low (n = 32, 25) 5 6
Platelets – Low (n = 32, 25) 6 3
WBC (White blood cells)-High (n = 32, 25) 1 1
WBC (White blood cells) – Low (n = 32, 25) 11 13
Lymphocytes – High (n = 32, 25) 1 0
Lymphocytes – Low (n = 32, 25) 6 5
Neutrophils – High (n = 32, 25) 3 1
Neutrophils – Low (n = 32, 25) 19 20
Partial thromboplastin Time – High (n = 32, 25) 1 1
Prothrombin time – High (n = 32, 25) 0 1
SGOT – High (n = 32, 25) 14 8
SGPT – High (n = 32, 25) 9 9
Alkaline phosphatase – High (n = 32, 25) 1 0
Phosphate – High (n = 32, 25) 1 1
Phosphate – Low (n = 32, 25) 2 3
Uric acid – High (n = 32, 25) 1 0
Triglycerides – High (n = 32, 25) 10 9
Thyroid-T4 – High (n = 32, 25) 6 0
Thyroid T4 – Low (n = 32, 25) 2 0
TSH – High (n = 32, 25) 3 1
9.Secondary Outcome
Title Number of Participants With Abnormal Vital Signs
Hide Description

Abnormal vital signs were defined as

  1. Systolic blood pressure (BP) below 85 mm Hg or above 180 mm Hg with a change from baseline of > 20%
  2. Diastolic BP above 110 mm Hg with a change from baseline of > 20% where systolic and diastolic BP were pressure exerted by blood on the walls of blood vessels during left ventricular systole and diastole respectively.
  3. Pulse rate below 50 beats per minute and above 120 beats per minute, with a change from baseline of > 20%, where pulse represents the palpation of heartbeat
Time Frame From screening (Day -21 to Day -1) to Week 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all enrolled participants who received at least one dose of study medication (Pegasys or ribavirin) and had at least one post-baseline safety assessment (defined as clinical adverse event, laboratory or vital sign data, physical examination finding, BDI-II score, or FSS score).
Arm/Group Title Non-Responders Non-Tolerators
Hide Arm/Group Description:
Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
Overall Number of Participants Analyzed 32 25
Measure Type: Number
Unit of Measure: Participants
Systolic BP high 1 0
Systolic BP low 1 0
Pulse-low 0 1
10.Secondary Outcome
Title Mean Score for Overall Local Injection Site Reaction
Hide Description Local injection-site reactions were to be given an overall assessment based on pain or discomfort as Grade 0 for no pain or discomfort, Grade 1 for mild tenderness at the injection site, Grade 2 for moderate pain without limitation of usual activities, Grade 3 for severe pain requiring prescription non-topical analgesics or limiting usual activities, Grade 4 for a reaction that resulted in a new hospitalization, prolongation of hospitalization, death, or a persistent or significant disability/incapacity, or was life threatening or medically significant. Adverse events related to the injection site (injection site erythema, hematoma, pain, rash, or reaction) were reported. All of these events were reported as resolved without sequelae.
Time Frame Baseline (Week 0), Week 4, 12, 24, 36, 48 and 60
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all enrolled participants who received at least one dose of study medication and had at least one post-baseline safety assessment (a clinical adverse event, laboratory, vital sign, or physical examination finding, BDI-II score, or FSS score). 'n' = number of participants available at the time of assessment.
Arm/Group Title Non-Responders Non-Tolerators
Hide Arm/Group Description:
Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
Overall Number of Participants Analyzed 32 25
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline, (n = 32, 25) 0.25  (0.57) 0.48  (0.65)
Week 4, (n = 31, 24) 0.03  (0.18) 0.08  (0.28)
Week 12, (n = 27, 24) 0.00  (0.00) 0.17  (0.38)
Week 24, (n = 2, 23) 0.00  (0.00) 0.09  (0.29)
Week 36, (n = 3, 19) 0.00  (0.00) 0.05  (0.23)
Week 48, n = (2, 0) 0.00  (0.00) NA [1]   (NA)
Week 60, n = (2, 0) 0.00  (0.00) NA [1]   (NA)
[1]
No participants in the "Non-Tolerators" provided data at Week 48 and 60.
Time Frame Up to Week 84
Adverse Event Reporting Description Safety Population included all the enrolled participants who received at least one dose of study medication (Pegasys or ribavirin) and had at least one post-baseline safety assessment (a clinical adverse event, laboratory, vital sign, or physical examination finding, BDI-II score or FSS score).
 
Arm/Group Title Non-Responders Non-Tolerators
Hide Arm/Group Description Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks. Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
All-Cause Mortality
Non-Responders Non-Tolerators
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Non-Responders Non-Tolerators
Affected / at Risk (%) Affected / at Risk (%)
Total   1/32 (3.13%)   1/25 (4.00%) 
Gastrointestinal disorders     
Abdominal pain  1  0/32 (0.00%)  1/25 (4.00%) 
Injury, poisoning and procedural complications     
Pelvic fracture  1  1/32 (3.13%)  0/25 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Non-Responders Non-Tolerators
Affected / at Risk (%) Affected / at Risk (%)
Total   27/32 (84.38%)   23/25 (92.00%) 
Blood and lymphatic system disorders     
ANAEMIA  1  2/32 (6.25%)  2/25 (8.00%) 
Ear and labyrinth disorders     
Ear pain  1  1/32 (3.13%)  2/25 (8.00%) 
Gastrointestinal disorders     
NAUSEA  1  6/32 (18.75%)  4/25 (16.00%) 
DIARRHOEA  1  3/32 (9.38%)  7/25 (28.00%) 
ABDOMINAL PAIN UPPER  1  3/32 (9.38%)  0/25 (0.00%) 
DRY MOUTH  1  1/32 (3.13%)  2/25 (8.00%) 
RECTAL HAEMORRHAGE  1  2/32 (6.25%)  0/25 (0.00%) 
ABDOMINAL PAIN  1  0/32 (0.00%)  2/25 (8.00%) 
CONSTIPATION  1  0/32 (0.00%)  2/25 (8.00%) 
VOMITING  1  0/32 (0.00%)  2/25 (8.00%) 
General disorders     
FATIGUE  1  10/32 (31.25%)  7/25 (28.00%) 
PYREXIA  1  2/32 (6.25%)  6/25 (24.00%) 
CHILLS  1  2/32 (6.25%)  3/25 (12.00%) 
INFLUENZA LIKE ILLNESS  1  1/32 (3.13%)  2/25 (8.00%) 
INJECTION SITE REACTION  1  0/32 (0.00%)  3/25 (12.00%) 
CHEST DISCOMFORT  1  2/32 (6.25%)  0/25 (0.00%) 
IRRITABILITY  1  0/32 (0.00%)  2/25 (8.00%) 
PAIN  1  0/32 (0.00%)  2/25 (8.00%) 
Infections and infestations     
UPPER RESPIRATORY TRACT INFECTION  1  2/32 (6.25%)  3/25 (12.00%) 
SINUSITIS  1  0/32 (0.00%)  2/25 (8.00%) 
Investigations     
WEIGHT DECREASED  1  1/32 (3.13%)  2/25 (8.00%) 
Metabolism and nutrition disorders     
DECREASED APPETITE  1  3/32 (9.38%)  1/25 (4.00%) 
Musculoskeletal and connective tissue disorders     
MYALGIA  1  6/32 (18.75%)  3/25 (12.00%) 
ARTHRALGIA  1  3/32 (9.38%)  3/25 (12.00%) 
MUSCULOSKELETAL PAIN  1  3/32 (9.38%)  0/25 (0.00%) 
PAIN IN EXTREMITY  1  0/32 (0.00%)  2/25 (8.00%) 
Nervous system disorders     
HEADACHE  1  7/32 (21.88%)  5/25 (20.00%) 
DIZZINESS  1  1/32 (3.13%)  3/25 (12.00%) 
HYPOAESTHESIA  1  1/32 (3.13%)  2/25 (8.00%) 
Psychiatric disorders     
INSOMNIA  1  11/32 (34.38%)  6/25 (24.00%) 
DEPRESSION  1  6/32 (18.75%)  5/25 (20.00%) 
ANXIETY  1  1/32 (3.13%)  2/25 (8.00%) 
Reproductive system and breast disorders     
ERECTILE DYSFUNCTION  1  2/32 (6.25%)  0/25 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
COUGH  1  5/32 (15.63%)  3/25 (12.00%) 
DYSPNOEA  1  2/32 (6.25%)  2/25 (8.00%) 
RHINORRHOEA  1  2/32 (6.25%)  1/25 (4.00%) 
EPISTAXIS  1  2/32 (6.25%)  0/25 (0.00%) 
THROAT IRRITATION  1  2/32 (6.25%)  0/25 (0.00%) 
Skin and subcutaneous tissue disorders     
RASH  1  6/32 (18.75%)  5/25 (20.00%) 
PRURITUS  1  3/32 (9.38%)  7/25 (28.00%) 
ALOPECIA  1  5/32 (15.63%)  2/25 (8.00%) 
HYPOTRICHOSIS  1  2/32 (6.25%)  1/25 (4.00%) 
PSORIASIS  1  2/32 (6.25%)  1/25 (4.00%) 
HYPERHIDROSIS  1  1/32 (3.13%)  2/25 (8.00%) 
DRY SKIN  1  0/32 (0.00%)  3/25 (12.00%) 
Vascular disorders     
HYPERTENSION  1  0/32 (0.00%)  2/25 (8.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.0
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
Name/Title: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
Phone: +41 616878333
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00087568     History of Changes
Other Study ID Numbers: ML16965
First Submitted: July 12, 2004
First Posted: July 14, 2004
Results First Submitted: February 3, 2016
Results First Posted: June 8, 2016
Last Update Posted: June 8, 2016