Trial Outcomes & Findings for 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 (NCT NCT00087568)
NCT ID: NCT00087568
Last Updated: 2016-06-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
57 participants
Primary outcome timeframe
36 weeks for Non-Tolerators and 60 weeks for Non-Responders
Results posted on
2016-06-08
Participant Flow
This study was conducted from 29 Jan 2003 to 24 Mar 2006 across 14 centers in the United States.
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).
Participant milestones
| Measure |
Non-Responders
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.
|
Non-Tolerators
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 Study
STARTED
|
32
|
25
|
|
Overall Study
COMPLETED
|
2
|
23
|
|
Overall Study
NOT COMPLETED
|
30
|
2
|
Reasons for withdrawal
| Measure |
Non-Responders
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.
|
Non-Tolerators
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 Study
Adverse Event
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
24
|
1
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Non-Responders
n=32 Participants
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.
|
Non-Tolerators
n=25 Participants
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
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.0 years
n=5 Participants
|
49.0 years
n=7 Participants
|
49.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 36 weeks for Non-Tolerators and 60 weeks for Non-RespondersPopulation: 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).
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.
Outcome measures
| Measure |
Non-Responders
n=32 Participants
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.
|
Non-Tolerators
n=25 Participants
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.
|
|---|---|---|
|
Number of Pegasys and Ribavirin Therapy Completers
Completing 36 weeks
|
3 Participants
|
23 Participants
|
|
Number of Pegasys and Ribavirin Therapy Completers
Completing 60 weeks
|
2 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 12, 24, 36, 48, 60, and 84Population: Intent to treat (ITT) Population included all enrolled participants who received at least one dose of study medication (Pegasys or ribavirin).
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.
Outcome measures
| Measure |
Non-Responders
n=32 Participants
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.
|
Non-Tolerators
n=25 Participants
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.
|
|---|---|---|
|
Number of Participants With >=2-log10 Decrease or Undetectable (<60 International Units Per Milliliter) Hepatitis C Virus-ribonucleic Acid Over Time
Week 4
|
1 Participants
|
16 Participants
|
|
Number of Participants With >=2-log10 Decrease or Undetectable (<60 International Units Per Milliliter) Hepatitis C Virus-ribonucleic Acid Over Time
Week 12
|
4 Participants
|
24 Participants
|
|
Number of Participants With >=2-log10 Decrease or Undetectable (<60 International Units Per Milliliter) Hepatitis C Virus-ribonucleic Acid Over Time
Week 24
|
1 Participants
|
21 Participants
|
|
Number of Participants With >=2-log10 Decrease or Undetectable (<60 International Units Per Milliliter) Hepatitis C Virus-ribonucleic Acid Over Time
Week 36
|
2 Participants
|
21 Participants
|
|
Number of Participants With >=2-log10 Decrease or Undetectable (<60 International Units Per Milliliter) Hepatitis C Virus-ribonucleic Acid Over Time
Week 48
|
1 Participants
|
11 Participants
|
|
Number of Participants With >=2-log10 Decrease or Undetectable (<60 International Units Per Milliliter) Hepatitis C Virus-ribonucleic Acid Over Time
Week 60
|
2 Participants
|
14 Participants
|
|
Number of Participants With >=2-log10 Decrease or Undetectable (<60 International Units Per Milliliter) Hepatitis C Virus-ribonucleic Acid Over Time
Week 84
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, and 84Population: ITT Population included all enrolled participants who received at least one dose of study medication (Pegasys or ribavirin).
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.
Outcome measures
| Measure |
Non-Responders
n=32 Participants
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.
|
Non-Tolerators
n=25 Participants
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.
|
|---|---|---|
|
Number of Participants With Normal Serum Alanine Transaminase Levels Over Time
Week 24
|
6 Participants
|
16 Participants
|
|
Number of Participants With Normal Serum Alanine Transaminase Levels Over Time
Baseline
|
21 Participants
|
21 Participants
|
|
Number of Participants With Normal Serum Alanine Transaminase Levels Over Time
Week 4
|
18 Participants
|
19 Participants
|
|
Number of Participants With Normal Serum Alanine Transaminase Levels Over Time
Week 12
|
9 Participants
|
19 Participants
|
|
Number of Participants With Normal Serum Alanine Transaminase Levels Over Time
Week 36
|
3 Participants
|
15 Participants
|
|
Number of Participants With Normal Serum Alanine Transaminase Levels Over Time
Week 48
|
3 Participants
|
14 Participants
|
|
Number of Participants With Normal Serum Alanine Transaminase Levels Over Time
Week 60
|
1 Participants
|
15 Participants
|
|
Number of Participants With Normal Serum Alanine Transaminase Levels Over Time
Week 84
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 84Population: 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).
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.
Outcome measures
| Measure |
Non-Responders
n=32 Participants
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.
|
Non-Tolerators
n=25 Participants
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.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events and Adverse Events
any AE
|
29 Participants
|
23 Participants
|
|
Number of Participants With Serious Adverse Events and Adverse Events
any SAE
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0); Weeks 4, 12, 24, 36, 48, 60, and 84Population: 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.
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.
Outcome measures
| Measure |
Non-Responders
n=32 Participants
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.
|
Non-Tolerators
n=25 Participants
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.
|
|---|---|---|
|
Mean Score of Beck Depression Inventory Over Time
Baseline, (n = 32, 25)
|
10.93 Units on a scale
Standard Deviation 9.32
|
15.03 Units on a scale
Standard Deviation 7.56
|
|
Mean Score of Beck Depression Inventory Over Time
Week 4, (n = 31, 24)
|
9.52 Units on a scale
Standard Deviation 8.34
|
10.68 Units on a scale
Standard Deviation 5.64
|
|
Mean Score of Beck Depression Inventory Over Time
Week 12, (n = 27, 24)
|
8.63 Units on a scale
Standard Deviation 7.74
|
10.76 Units on a scale
Standard Deviation 7.97
|
|
Mean Score of Beck Depression Inventory Over Time
Week 24, (n = 2, 23)
|
3.75 Units on a scale
Standard Deviation 0.64
|
11.26 Units on a scale
Standard Deviation 7.30
|
|
Mean Score of Beck Depression Inventory Over Time
Week 36, (n = 3, 19)
|
5.40 Units on a scale
Standard Deviation 3.83
|
8.65 Units on a scale
Standard Deviation 5.73
|
|
Mean Score of Beck Depression Inventory Over Time
Week 48, (n = 2, 21)
|
6.15 Units on a scale
Standard Deviation 4.03
|
4.30 Units on a scale
Standard Deviation 4.54
|
|
Mean Score of Beck Depression Inventory Over Time
Week 60, (n = 2, 21)
|
3.00 Units on a scale
Standard Deviation 4.24
|
3.62 Units on a scale
Standard Deviation 3.40
|
|
Mean Score of Beck Depression Inventory Over Time
Week 84, (n = 2, 0)
|
1.50 Units on a scale
Standard Deviation 2.12
|
NA Units on a scale
Standard Deviation NA
No participants in the "Non-Tolerators" provided data at Week 84
|
SECONDARY outcome
Timeframe: Baseline (Week 0); Weeks 4, 12, 24, 36, 48, 60, and 84Population: 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.
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.
Outcome measures
| Measure |
Non-Responders
n=32 Participants
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.
|
Non-Tolerators
n=25 Participants
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.
|
|---|---|---|
|
Mean Score of Fatigue Severity Over Time
Total FSS, Week 60, (n = 2, 20)
|
2.44 Units on a scale
Standard Deviation 2.04
|
2.97 Units on a scale
Standard Deviation 1.13
|
|
Mean Score of Fatigue Severity Over Time
Visual analog based FSS, Week 36, (n = 3, 19)
|
47.33 Units on a scale
Standard Deviation 16.65
|
48.79 Units on a scale
Standard Deviation 29.09
|
|
Mean Score of Fatigue Severity Over Time
Visual analog based FSS, Week 60, (n = 2, 20
|
31.00 Units on a scale
Standard Deviation 2.83
|
31.55 Units on a scale
Standard Deviation 32.45
|
|
Mean Score of Fatigue Severity Over Time
Total FSS, Baseline, (n = 32, 25)
|
4.66 Units on a scale
Standard Deviation 1.73
|
5.14 Units on a scale
Standard Deviation 1.27
|
|
Mean Score of Fatigue Severity Over Time
Total FSS, Week 4, (n = 31, 24)
|
4.27 Units on a scale
Standard Deviation 1.76
|
4.50 Units on a scale
Standard Deviation 1.59
|
|
Mean Score of Fatigue Severity Over Time
Total FSS, Week 12, (n = 27, 24)
|
4.09 Units on a scale
Standard Deviation 1.84
|
4.72 Units on a scale
Standard Deviation 1.72
|
|
Mean Score of Fatigue Severity Over Time
Total FSS, Week 24, (n = 2, 23)
|
1.33 Units on a scale
Standard Deviation 0.47
|
4.99 Units on a scale
Standard Deviation 1.56
|
|
Mean Score of Fatigue Severity Over Time
Total FSS, Week 36,(n = 3, 19)
|
2.52 Units on a scale
Standard Deviation 1.41
|
4.62 Units on a scale
Standard Deviation 1.75
|
|
Mean Score of Fatigue Severity Over Time
Total FSS, Week 48, (n = 2, 21)
|
2.22 Units on a scale
Standard Deviation 1.73
|
3.17 Units on a scale
Standard Deviation 1.17
|
|
Mean Score of Fatigue Severity Over Time
Total FSS, Week 84, (n = 2, 0)
|
1.61 Units on a scale
Standard Deviation 0.86
|
NA Units on a scale
Standard Deviation NA
No participants in the "Non-Tolerators" provided data at Week 84
|
|
Mean Score of Fatigue Severity Over Time
Visual analog based FSS, Baseline, (n = 32, 25)
|
48.72 Units on a scale
Standard Deviation 25.64
|
61.92 Units on a scale
Standard Deviation 23.38
|
|
Mean Score of Fatigue Severity Over Time
Visual analog based FSS, Week 4, (n = 31, 24)
|
47.87 Units on a scale
Standard Deviation 29.67
|
52.08 Units on a scale
Standard Deviation 25.92
|
|
Mean Score of Fatigue Severity Over Time
Visual analog based FSS, Week 12, (n = 27, 24)
|
52.15 Units on a scale
Standard Deviation 31.52
|
55.00 Units on a scale
Standard Deviation 26.96
|
|
Mean Score of Fatigue Severity Over Time
Visual analog based FSS, Week 24, (n = 2, 23)
|
54.50 Units on a scale
Standard Deviation 19.09
|
56.52 Units on a scale
Standard Deviation 28.70
|
|
Mean Score of Fatigue Severity Over Time
Visual analog based FSS, Week 48, (n = 2, 21)
|
26.00 Units on a scale
Standard Deviation 1.41
|
25.24 Units on a scale
Standard Deviation 22.27
|
|
Mean Score of Fatigue Severity Over Time
Visual analog based FSS, Week 84, (n = 2, 0)
|
21.50 Units on a scale
Standard Deviation 16.26
|
NA Units on a scale
Standard Deviation NA
No participants in the "Non-Tolerators" provided data at Week 84
|
SECONDARY outcome
Timeframe: Baseline (Week 0); Weeks 12, 36, 60 and 84Population: 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.
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.
Outcome measures
| Measure |
Non-Responders
n=32 Participants
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.
|
Non-Tolerators
n=25 Participants
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.
|
|---|---|---|
|
Number of Participants With Individual Flu-like Symptom
Week 36, Fever, (n = 3, 19)
|
1 Participants
|
3 Participants
|
|
Number of Participants With Individual Flu-like Symptom
Week 36, Muscle aches, (n = 3, 19)
|
1 Participants
|
8 Participants
|
|
Number of Participants With Individual Flu-like Symptom
Week 84, Headache, (n = 32, 25)
|
19 Participants
|
18 Participants
|
|
Number of Participants With Individual Flu-like Symptom
Week 84, Fever, (n = 32, 25)
|
10 Participants
|
14 Participants
|
|
Number of Participants With Individual Flu-like Symptom
Baseline, Headache, (n = 32, 25)
|
16 Participants
|
19 Participants
|
|
Number of Participants With Individual Flu-like Symptom
Baseline, Fever, (n = 32, 25)
|
10 Participants
|
14 Participants
|
|
Number of Participants With Individual Flu-like Symptom
Baseline, Muscle aches, (n = 32, 25)
|
17 Participants
|
21 Participants
|
|
Number of Participants With Individual Flu-like Symptom
Baseline, Chills, (n = 32, 25)
|
12 Participants
|
17 Participants
|
|
Number of Participants With Individual Flu-like Symptom
Week 12, Headache, (n = 27, 24)
|
13 Participants
|
13 Participants
|
|
Number of Participants With Individual Flu-like Symptom
Week 12, Fever, (n = 27, 24)
|
3 Participants
|
5 Participants
|
|
Number of Participants With Individual Flu-like Symptom
Week 12, Muscle aches, (n = 27, 24)
|
8 Participants
|
10 Participants
|
|
Number of Participants With Individual Flu-like Symptom
Week 12, Chills, (n = 27, 24)
|
2 Participants
|
5 Participants
|
|
Number of Participants With Individual Flu-like Symptom
Week 36, Headache, (n = 3, 19)
|
2 Participants
|
10 Participants
|
|
Number of Participants With Individual Flu-like Symptom
Week 36, Chills, (n = 3, 19)
|
1 Participants
|
7 Participants
|
|
Number of Participants With Individual Flu-like Symptom
Week 60, Headache, (n = 2, 22)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Individual Flu-like Symptom
Week 60, Fever, (n = 2, 22)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Individual Flu-like Symptom
Week 60, Muscle aches, (n = 2, 22)
|
0 Participants
|
2 Participants
|
|
Number of Participants With Individual Flu-like Symptom
Week 60, Chills, (n = 2, 22)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Individual Flu-like Symptom
Week 84, Muscle aches, (n = 32, 25)
|
18 Participants
|
19 Participants
|
|
Number of Participants With Individual Flu-like Symptom
Week 84, Chills, (n = 32, 25)
|
9 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Up to Week 84Population: 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.
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
Outcome measures
| Measure |
Non-Responders
n=32 Participants
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.
|
Non-Tolerators
n=25 Participants
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.
|
|---|---|---|
|
Number of Participants With Marked Laboratory Abnormalities
Lymphocytes - Low (n = 32, 25)
|
6 participants
|
5 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Neutrophils - Low (n = 32, 25)
|
19 participants
|
20 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Phosphate - Low (n = 32, 25)
|
2 participants
|
3 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Uric acid - High (n = 32, 25)
|
1 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Hematocrit (fraction) - Low (n = 32, 25)
|
5 participants
|
3 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Hemoglobin-Low (n = 32, 25)
|
5 participants
|
6 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Platelets - Low (n = 32, 25)
|
6 participants
|
3 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
WBC (White blood cells)-High (n = 32, 25)
|
1 participants
|
1 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
WBC (White blood cells) - Low (n = 32, 25)
|
11 participants
|
13 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Lymphocytes - High (n = 32, 25)
|
1 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Neutrophils - High (n = 32, 25)
|
3 participants
|
1 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Partial thromboplastin Time - High (n = 32, 25)
|
1 participants
|
1 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Prothrombin time - High (n = 32, 25)
|
0 participants
|
1 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
SGOT - High (n = 32, 25)
|
14 participants
|
8 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
SGPT - High (n = 32, 25)
|
9 participants
|
9 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Alkaline phosphatase - High (n = 32, 25)
|
1 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Phosphate - High (n = 32, 25)
|
1 participants
|
1 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Triglycerides - High (n = 32, 25)
|
10 participants
|
9 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Thyroid-T4 - High (n = 32, 25)
|
6 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Thyroid T4 - Low (n = 32, 25)
|
2 participants
|
0 participants
|
|
Number of Participants With Marked Laboratory Abnormalities
TSH - High (n = 32, 25)
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: From screening (Day -21 to Day -1) to Week 84Population: 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).
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
Outcome measures
| Measure |
Non-Responders
n=32 Participants
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.
|
Non-Tolerators
n=25 Participants
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.
|
|---|---|---|
|
Number of Participants With Abnormal Vital Signs
Systolic BP high
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Systolic BP low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Pulse-low
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, 12, 24, 36, 48 and 60Population: 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.
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.
Outcome measures
| Measure |
Non-Responders
n=32 Participants
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.
|
Non-Tolerators
n=25 Participants
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.
|
|---|---|---|
|
Mean Score for Overall Local Injection Site Reaction
Week 4, (n = 31, 24)
|
0.03 Units on a scale
Standard Deviation 0.18
|
0.08 Units on a scale
Standard Deviation 0.28
|
|
Mean Score for Overall Local Injection Site Reaction
Baseline, (n = 32, 25)
|
0.25 Units on a scale
Standard Deviation 0.57
|
0.48 Units on a scale
Standard Deviation 0.65
|
|
Mean Score for Overall Local Injection Site Reaction
Week 12, (n = 27, 24)
|
0.00 Units on a scale
Standard Deviation 0.00
|
0.17 Units on a scale
Standard Deviation 0.38
|
|
Mean Score for Overall Local Injection Site Reaction
Week 24, (n = 2, 23)
|
0.00 Units on a scale
Standard Deviation 0.00
|
0.09 Units on a scale
Standard Deviation 0.29
|
|
Mean Score for Overall Local Injection Site Reaction
Week 36, (n = 3, 19)
|
0.00 Units on a scale
Standard Deviation 0.00
|
0.05 Units on a scale
Standard Deviation 0.23
|
|
Mean Score for Overall Local Injection Site Reaction
Week 48, n = (2, 0)
|
0.00 Units on a scale
Standard Deviation 0.00
|
NA Units on a scale
Standard Deviation NA
No participants in the "Non-Tolerators" provided data at Week 48 and 60.
|
|
Mean Score for Overall Local Injection Site Reaction
Week 60, n = (2, 0)
|
0.00 Units on a scale
Standard Deviation 0.00
|
NA Units on a scale
Standard Deviation NA
No participants in the "Non-Tolerators" provided data at Week 48 and 60.
|
Adverse Events
Non-Responders
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Non-Tolerators
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Non-Responders
n=32 participants at risk
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.
|
Non-Tolerators
n=25 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/32 • Up to Week 84
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).
|
4.0%
1/25 • Up to Week 84
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).
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
3.1%
1/32 • Up to Week 84
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).
|
0.00%
0/25 • Up to Week 84
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).
|
Other adverse events
| Measure |
Non-Responders
n=32 participants at risk
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.
|
Non-Tolerators
n=25 participants at risk
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.
|
|---|---|---|
|
General disorders
FATIGUE
|
31.2%
10/32 • Up to Week 84
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).
|
28.0%
7/25 • Up to Week 84
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).
|
|
General disorders
PYREXIA
|
6.2%
2/32 • Up to Week 84
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).
|
24.0%
6/25 • Up to Week 84
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).
|
|
General disorders
CHILLS
|
6.2%
2/32 • Up to Week 84
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).
|
12.0%
3/25 • Up to Week 84
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).
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
3.1%
1/32 • Up to Week 84
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).
|
8.0%
2/25 • Up to Week 84
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).
|
|
General disorders
INJECTION SITE REACTION
|
0.00%
0/32 • Up to Week 84
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).
|
12.0%
3/25 • Up to Week 84
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).
|
|
General disorders
CHEST DISCOMFORT
|
6.2%
2/32 • Up to Week 84
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).
|
0.00%
0/25 • Up to Week 84
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).
|
|
General disorders
IRRITABILITY
|
0.00%
0/32 • Up to Week 84
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).
|
8.0%
2/25 • Up to Week 84
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).
|
|
General disorders
PAIN
|
0.00%
0/32 • Up to Week 84
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).
|
8.0%
2/25 • Up to Week 84
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).
|
|
Skin and subcutaneous tissue disorders
RASH
|
18.8%
6/32 • Up to Week 84
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).
|
20.0%
5/25 • Up to Week 84
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).
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
9.4%
3/32 • Up to Week 84
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).
|
28.0%
7/25 • Up to Week 84
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).
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
15.6%
5/32 • Up to Week 84
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).
|
8.0%
2/25 • Up to Week 84
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).
|
|
Skin and subcutaneous tissue disorders
HYPOTRICHOSIS
|
6.2%
2/32 • Up to Week 84
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).
|
4.0%
1/25 • Up to Week 84
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).
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
6.2%
2/32 • Up to Week 84
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).
|
4.0%
1/25 • Up to Week 84
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).
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
3.1%
1/32 • Up to Week 84
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).
|
8.0%
2/25 • Up to Week 84
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).
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/32 • Up to Week 84
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).
|
12.0%
3/25 • Up to Week 84
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).
|
|
Gastrointestinal disorders
NAUSEA
|
18.8%
6/32 • Up to Week 84
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).
|
16.0%
4/25 • Up to Week 84
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).
|
|
Gastrointestinal disorders
DIARRHOEA
|
9.4%
3/32 • Up to Week 84
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).
|
28.0%
7/25 • Up to Week 84
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).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
9.4%
3/32 • Up to Week 84
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).
|
0.00%
0/25 • Up to Week 84
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).
|
|
Gastrointestinal disorders
DRY MOUTH
|
3.1%
1/32 • Up to Week 84
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).
|
8.0%
2/25 • Up to Week 84
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).
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
6.2%
2/32 • Up to Week 84
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).
|
0.00%
0/25 • Up to Week 84
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).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/32 • Up to Week 84
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).
|
8.0%
2/25 • Up to Week 84
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).
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/32 • Up to Week 84
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).
|
8.0%
2/25 • Up to Week 84
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).
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/32 • Up to Week 84
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).
|
8.0%
2/25 • Up to Week 84
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).
|
|
Psychiatric disorders
INSOMNIA
|
34.4%
11/32 • Up to Week 84
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).
|
24.0%
6/25 • Up to Week 84
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).
|
|
Psychiatric disorders
DEPRESSION
|
18.8%
6/32 • Up to Week 84
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).
|
20.0%
5/25 • Up to Week 84
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).
|
|
Psychiatric disorders
ANXIETY
|
3.1%
1/32 • Up to Week 84
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).
|
8.0%
2/25 • Up to Week 84
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).
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
18.8%
6/32 • Up to Week 84
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).
|
12.0%
3/25 • Up to Week 84
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).
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
9.4%
3/32 • Up to Week 84
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).
|
12.0%
3/25 • Up to Week 84
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).
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
9.4%
3/32 • Up to Week 84
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).
|
0.00%
0/25 • Up to Week 84
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).
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/32 • Up to Week 84
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).
|
8.0%
2/25 • Up to Week 84
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).
|
|
Nervous system disorders
HEADACHE
|
21.9%
7/32 • Up to Week 84
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).
|
20.0%
5/25 • Up to Week 84
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).
|
|
Nervous system disorders
DIZZINESS
|
3.1%
1/32 • Up to Week 84
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).
|
12.0%
3/25 • Up to Week 84
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).
|
|
Nervous system disorders
HYPOAESTHESIA
|
3.1%
1/32 • Up to Week 84
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).
|
8.0%
2/25 • Up to Week 84
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).
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
15.6%
5/32 • Up to Week 84
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).
|
12.0%
3/25 • Up to Week 84
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).
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
6.2%
2/32 • Up to Week 84
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).
|
8.0%
2/25 • Up to Week 84
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).
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
6.2%
2/32 • Up to Week 84
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).
|
4.0%
1/25 • Up to Week 84
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).
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
6.2%
2/32 • Up to Week 84
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).
|
0.00%
0/25 • Up to Week 84
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).
|
|
Respiratory, thoracic and mediastinal disorders
THROAT IRRITATION
|
6.2%
2/32 • Up to Week 84
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).
|
0.00%
0/25 • Up to Week 84
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).
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
6.2%
2/32 • Up to Week 84
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).
|
12.0%
3/25 • Up to Week 84
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).
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/32 • Up to Week 84
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).
|
8.0%
2/25 • Up to Week 84
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).
|
|
Blood and lymphatic system disorders
ANAEMIA
|
6.2%
2/32 • Up to Week 84
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).
|
8.0%
2/25 • Up to Week 84
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).
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
9.4%
3/32 • Up to Week 84
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).
|
4.0%
1/25 • Up to Week 84
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).
|
|
Ear and labyrinth disorders
Ear pain
|
3.1%
1/32 • Up to Week 84
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).
|
8.0%
2/25 • Up to Week 84
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).
|
|
Investigations
WEIGHT DECREASED
|
3.1%
1/32 • Up to Week 84
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).
|
8.0%
2/25 • Up to Week 84
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).
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
6.2%
2/32 • Up to Week 84
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).
|
0.00%
0/25 • Up to Week 84
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).
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/32 • Up to Week 84
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).
|
8.0%
2/25 • Up to Week 84
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).
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Phone: +41 616878333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER