Trial Outcomes & Findings for An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Copegus (Ribavirin) in Participants With Chronic Hepatitis C (CHC), Genotype 2, 3, 1 or 4, Undergoing Opioid Maintenance Therapy (NCT NCT01416610)
NCT ID: NCT01416610
Last Updated: 2017-04-10
Results Overview
SVR24 is defined as percentage of participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment, using a last observation carried forward (LOCF) approach. Percentage is based on the number of non-missing observations (total).
COMPLETED
88 participants
24 weeks after completing treatment, within 3 years, 6 months
2017-04-10
Participant Flow
Participant milestones
| Measure |
All Participants
Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
|
|---|---|
|
Overall Study
STARTED
|
88
|
|
Overall Study
Intention to Treat
|
88
|
|
Overall Study
Safety Population
|
86
|
|
Overall Study
Per Protocol
|
83
|
|
Overall Study
Completed Treatment
|
47
|
|
Overall Study
Completed Follow-up
|
45
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
43
|
Reasons for withdrawal
| Measure |
All Participants
Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Adverse Event -Patient decision
|
3
|
|
Overall Study
Lack of Efficacy
|
4
|
|
Overall Study
No reason given
|
5
|
|
Overall Study
Withdrawal by Subject
|
13
|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Sufficient treatment duration (PCR neg.)
|
7
|
Baseline Characteristics
An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Copegus (Ribavirin) in Participants With Chronic Hepatitis C (CHC), Genotype 2, 3, 1 or 4, Undergoing Opioid Maintenance Therapy
Baseline characteristics by cohort
| Measure |
All Participants
n=88 Participants
Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
|
|---|---|
|
Age, Continuous
|
34.6 years
STANDARD_DEVIATION 8.5 • n=113 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=113 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=113 Participants
|
|
Region of Enrollment
Austria
|
88 participants
n=113 Participants
|
PRIMARY outcome
Timeframe: 24 weeks after completing treatment, within 3 years, 6 monthsSVR24 is defined as percentage of participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment, using a last observation carried forward (LOCF) approach. Percentage is based on the number of non-missing observations (total).
Outcome measures
| Measure |
All Participants
n=88 Participants
Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
|
Week 12
Week 12 Visit
|
End of Treatment
End of Treatment Visit
|
End of Follow-up
End of Follow-up Visit
|
|---|---|---|---|---|
|
Percentage of Participants With Sustained Virological Response 24 Weeks After Completing Treatment (SVR24)
|
83.0 percentage of participants
Interval 73.8 to 89.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeks after completing treatment, within 3 years, 6 monthsSVR 12 is defined as percentage of participants with undetectable HCV RNA 12 weeks after completing treatment, using a LOCF approach. Percentage is based on the number of non-missing observations (total).
Outcome measures
| Measure |
All Participants
n=88 Participants
Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
|
Week 12
Week 12 Visit
|
End of Treatment
End of Treatment Visit
|
End of Follow-up
End of Follow-up Visit
|
|---|---|---|---|---|
|
Percentage of Participants With SVR 12
|
81.8 percentage of participants
Interval 72.5 to 88.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at end of treatment, within 3 years, 6 monthsA participant was considered to have end of treatment response if there was undetectable HCV RNA after completing treatment, using a LOCF approach. Percentage is based on the number of non-missing observations (total).
Outcome measures
| Measure |
All Participants
n=88 Participants
Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
|
Week 12
Week 12 Visit
|
End of Treatment
End of Treatment Visit
|
End of Follow-up
End of Follow-up Visit
|
|---|---|---|---|---|
|
Percentage of Participants With End of Treatment Response
|
87.5 percentage of participants
Interval 79.0 to 92.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: by end of follow-up, within 3 years, 6 monthsPopulation: Participants who completed treatment
Virological relapse is defined as no SVR24 in a participant with undetectable HCV RNA at end of treatment who has at least one post-treatment polymerase chain reaction (PCR) result available, using a LOCF approach. Percentage is based on the number of non-missing observations (total).
Outcome measures
| Measure |
All Participants
n=47 Participants
Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
|
Week 12
Week 12 Visit
|
End of Treatment
End of Treatment Visit
|
End of Follow-up
End of Follow-up Visit
|
|---|---|---|---|---|
|
Percentage of Participants With Virological Relapse
|
10.6 percentage of participants
Interval 4.6 to 22.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 monthsPopulation: Participants with a viable score at the given time point
The SF-36 questionnaire items were scored and transformed according to the SF-36 Health Survey Manual \& Interpretation Guide. Summary scores for SF-36 dimensions of physical functioning, role functioning, bodily pain, general health, vitality, social functioning, and mental health were scored on a scale of 0 (worst) to 100 (best), and health transition was scored on a scale of 0 (worst) to 5 (best). Summary SF-36 scores are reported by category and by visit.
Outcome measures
| Measure |
All Participants
n=88 Participants
Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
|
Week 12
n=88 Participants
Week 12 Visit
|
End of Treatment
n=88 Participants
End of Treatment Visit
|
End of Follow-up
n=88 Participants
End of Follow-up Visit
|
|---|---|---|---|---|
|
Short Form Health Survey (SF-36) Scores by Visit
Social Functioning (n=53,35,37,23)
|
69.8 units on a scale
Standard Deviation 27.1
|
52.5 units on a scale
Standard Deviation 28.6
|
48.0 units on a scale
Standard Deviation 27.4
|
72.3 units on a scale
Standard Deviation 32.6
|
|
Short Form Health Survey (SF-36) Scores by Visit
Physical Functioning (n=54,34,37,22)
|
77.9 units on a scale
Standard Deviation 21.7
|
63.5 units on a scale
Standard Deviation 25.1
|
62.7 units on a scale
Standard Deviation 22.3
|
76.1 units on a scale
Standard Deviation 26.5
|
|
Short Form Health Survey (SF-36) Scores by Visit
Role Functioning - Physical (n=52,34,37,22)
|
60.6 units on a scale
Standard Deviation 40.9
|
32.4 units on a scale
Standard Deviation 37.7
|
24.3 units on a scale
Standard Deviation 37.0
|
70.5 units on a scale
Standard Deviation 39.1
|
|
Short Form Health Survey (SF-36) Scores by Visit
Bodily Pain (n=53,35,37,22)
|
70.8 units on a scale
Standard Deviation 27.7
|
58.7 units on a scale
Standard Deviation 29.3
|
52.5 units on a scale
Standard Deviation 27.8
|
75.4 units on a scale
Standard Deviation 29.7
|
|
Short Form Health Survey (SF-36) Scores by Visit
General Health (n=50,35,36,22)
|
50.9 units on a scale
Standard Deviation 18.9
|
46.1 units on a scale
Standard Deviation 18.6
|
50.5 units on a scale
Standard Deviation 18.7
|
65.4 units on a scale
Standard Deviation 19.3
|
|
Short Form Health Survey (SF-36) Scores by Visit
Vitality (n=52,35,37,22)
|
42.8 units on a scale
Standard Deviation 21.5
|
26.1 units on a scale
Standard Deviation 19.3
|
33.9 units on a scale
Standard Deviation 20.2
|
48.6 units on a scale
Standard Deviation 20.0
|
|
Short Form Health Survey (SF-36) Scores by Visit
Role Functioning - Emotional (n=53,34,36,22)
|
57.2 units on a scale
Standard Deviation 44.0
|
31.4 units on a scale
Standard Deviation 37.6
|
31.5 units on a scale
Standard Deviation 36.5
|
69.7 units on a scale
Standard Deviation 37.0
|
|
Short Form Health Survey (SF-36) Scores by Visit
Mental Health (n=52,34,37,22)
|
59.1 units on a scale
Standard Deviation 19.2
|
49.4 units on a scale
Standard Deviation 19.8
|
51.7 units on a scale
Standard Deviation 22.4
|
67.2 units on a scale
Standard Deviation 25.7
|
|
Short Form Health Survey (SF-36) Scores by Visit
Reported Health Transition (n=54,34,37,22)
|
3.3 units on a scale
Standard Deviation 1.2
|
3.6 units on a scale
Standard Deviation 1.2
|
3.2 units on a scale
Standard Deviation 1.5
|
2.0 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 monthsPopulation: Participants with a viable score at the given time point
The Fatigue Severity Scale (FSS) consists of 9 questions, each answered within a range of 1-7, where lower scores indicate less fatigue in everyday life. The FSS score is the mean of the 9 numbers. Mean scores are presented by visit.
Outcome measures
| Measure |
All Participants
n=88 Participants
Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
|
Week 12
Week 12 Visit
|
End of Treatment
End of Treatment Visit
|
End of Follow-up
End of Follow-up Visit
|
|---|---|---|---|---|
|
Fatigue Severity Scale (FSS) Score by Visit
Baseline (n=56)
|
4.0 units on a scale
Standard Deviation 1.4
|
—
|
—
|
—
|
|
Fatigue Severity Scale (FSS) Score by Visit
Week 12 (n=35)
|
5.0 units on a scale
Standard Deviation 1.3
|
—
|
—
|
—
|
|
Fatigue Severity Scale (FSS) Score by Visit
End of treatment (n=37)
|
5.0 units on a scale
Standard Deviation 1.4
|
—
|
—
|
—
|
|
Fatigue Severity Scale (FSS) Score by Visit
End of follow-up (n=24)
|
3.8 units on a scale
Standard Deviation 1.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 monthsPopulation: Participants with a viable score at the given time point
The BL questionnaire items were scored by calculating the average response to all answered items. Items can be graded 1="stark" (affliction is strong) to 4="gar nicht" (not present). The higher the BL score, the less afflictions were present for a participant. Mean scores are presented by visit.
Outcome measures
| Measure |
All Participants
n=88 Participants
Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
|
Week 12
Week 12 Visit
|
End of Treatment
End of Treatment Visit
|
End of Follow-up
End of Follow-up Visit
|
|---|---|---|---|---|
|
Beschwerdeliste (BL) Score by Visit
Baseline (n=59)
|
3.1 units on a scale
Standard Deviation 0.5
|
—
|
—
|
—
|
|
Beschwerdeliste (BL) Score by Visit
Week 12 (n=34)
|
2.8 units on a scale
Standard Deviation 0.5
|
—
|
—
|
—
|
|
Beschwerdeliste (BL) Score by Visit
End of treatment (n=36)
|
2.7 units on a scale
Standard Deviation 0.5
|
—
|
—
|
—
|
|
Beschwerdeliste (BL) Score by Visit
End of follow-up (n=24)
|
3.1 units on a scale
Standard Deviation 0.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 monthsPopulation: Participants with a viable score at the given time point
The BDI questionnaire items were scored by generating the sum of the responses to all answered items. Each result was categorized into one of four categories: 0-13= no depression or clinically not significant or in remission; 14-19= mild depression; 20-28= moderate depression; or 29-63= severe depression. Mean scores are presented by visit.
Outcome measures
| Measure |
All Participants
n=88 Participants
Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
|
Week 12
Week 12 Visit
|
End of Treatment
End of Treatment Visit
|
End of Follow-up
End of Follow-up Visit
|
|---|---|---|---|---|
|
Beck Depression Inventory (BDI) Score by Visit
Baseline (n=50)
|
13.7 units on a scale
Standard Deviation 9.0
|
—
|
—
|
—
|
|
Beck Depression Inventory (BDI) Score by Visit
Week 12 (n=33)
|
18.4 units on a scale
Standard Deviation 11.1
|
—
|
—
|
—
|
|
Beck Depression Inventory (BDI) Score by Visit
End of treatment (n=33)
|
16.9 units on a scale
Standard Deviation 9.4
|
—
|
—
|
—
|
|
Beck Depression Inventory (BDI) Score by Visit
End of follow-up (n=22)
|
11.6 units on a scale
Standard Deviation 10.7
|
—
|
—
|
—
|
Adverse Events
Safety Population
Serious adverse events
| Measure |
Safety Population
n=86 participants at risk
Participants who started treatment
|
|---|---|
|
Infections and infestations
Abscess limb
|
1.2%
1/86
|
|
Infections and infestations
Erysipelas
|
1.2%
1/86
|
|
Infections and infestations
Herpes zoster
|
1.2%
1/86
|
|
Infections and infestations
Pneumonia
|
1.2%
1/86
|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
2/86
|
|
General disorders
Drug withdrawal syndrome
|
2.3%
2/86
|
|
Psychiatric disorders
Anorexia nervosa
|
1.2%
1/86
|
|
Psychiatric disorders
Withdrawal syndrome
|
1.2%
1/86
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.2%
1/86
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.2%
1/86
|
|
Reproductive system and breast disorders
Uterine cyst
|
1.2%
1/86
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.2%
1/86
|
Other adverse events
| Measure |
Safety Population
n=86 participants at risk
Participants who started treatment
|
|---|---|
|
General disorders
Fatigue
|
48.8%
42/86
|
|
General disorders
Influenza like illness
|
16.3%
14/86
|
|
General disorders
Pyrexia
|
11.6%
10/86
|
|
Psychiatric disorders
Depression
|
26.7%
23/86
|
|
Psychiatric disorders
Insomnia
|
7.0%
6/86
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.5%
9/86
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.0%
6/86
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.0%
6/86
|
|
Blood and lymphatic system disorders
Anaemia
|
17.4%
15/86
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.4%
15/86
|
|
Nervous system disorders
Headache
|
16.3%
14/86
|
|
Gastrointestinal disorders
Nausea
|
15.1%
13/86
|
|
Investigations
Weight decreased
|
9.3%
8/86
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.0%
6/86
|
Additional Information
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