Phase 4
Completed N=48
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Enrolled in a Methadone Maintenance Treatment Program.
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00087594 ↗
Enrolled (actual)
48
Serious AEs
12.5%
Results posted
Mar 2016
Primary outcomePrimary: Number of Participants With Treatment Completion Rate (TCR) — 9; 10; 4; 5 participants
Summary
This study will evaluate the safety and tolerability of PEGASYS plus ribavirin in previous intravenous (iv) drug users who have CHC and are currently enrolled in a methadone maintenance treatment program. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Completion Rate (TCR) |
9; 10; 4; 5; 4; 4 | — |
| SECONDARY Number of Participants With Sustained Virological Response (SVR) Rate at 24 Weeks Post Treatment (Week 48 for G2/3 and Week 72 for G1) |
4; 5; 10; 2 | — |
| SECONDARY Number of Participants With Virological Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 Weeks After Treatment Completion |
3; 5; 5; 8; 5; 8 | — |
| SECONDARY Number of Participants With Biochemical Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 and 24 Weeks After Treatment Completion |
3; 13; 5; 13; 4; 5 | — |
| SECONDARY Number of Participants With > =2 Log Drop From Baseline or Undetectable HCV-RNA (<10 IU/mL) at Week 12 |
4; 9; 11; 8 | — |
| SECONDARY Mean Absolute Score of Beck Depression Inventory, Second Edition (BDI-II) |
8.7; 8.6; 13.6; 22.8; 8.6; 13.4 | — |
| SECONDARY Mean Change From Baseline in BDI-II Score to EOT (Week 24/48) and EOS (Week 48/72) Visits |
6.1; 13.5; 0.4; 4.5 | — |
| SECONDARY Number of Participants With Degrees of Depression as Defined by the BDI-II Score |
22; 24; 2; 0; 16; 9 | — |
| SECONDARY Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit |
70.7; 75.5; 50.0; 35.4; 72.8; 59.2 | — |
| SECONDARY Number of Participants With Compliance to the Prescribed Treatment Regimen |
8; 8; 0; 1; 1; 4 | — |
| SECONDARY Number of Participants With Abnormal Vital Signs |
1; 0; 1; 0; 2; 0 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities (Hematology) |
10; 11; 10; 16; 11; 10 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities (Biochemistry) |
2; 8; 2; 4; 0; 4 | — |
| SECONDARY Number of Participants With Any Adverse Events (AEs), Any Serious Adverse Events (SAEs), and Study Discontinuation |
24; 24; 3; 3; 2; 3 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients at least 18 years of age
- CHC infection, genotype 1, 2, or 3
- naive to treatment for CHC infection
- enrolled in a methadone maintenance program with documented attendance for at least 3 months
- use of 2 forms of contraception during the study on both men and women
Exclusion Criteria
- previous treatment for CHC infection
- co-infection with human immunodeficiency virus (HIV)
- current use of IV or other illicit drugs
- decompensated cirrhosis
- women who are pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT00087594). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.