N/A
Completed N=348
Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Participants With/Without Substitution Therapy (P05255)
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00725751 ↗
Enrolled (actual)
348
Serious AEs
3.2%
Results posted
Apr 2012
Primary outcomePrimary: Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin — 56; 150 participants
Summary
Although injection drug users represent the majority of new and existing cases of infection with hepatitis C virus (HCV), many lack access to treatment because of concerns about adherence, effectiveness, and reinfection. On the basis of a small but growing body of evidence showing that injection drug users can undergo treatment for HCV infection successfully, the 2002 NIH Consensus Statement on Hepatitis C has recommended that substance users be treated for HCV infection on a case-by-case basis. In this study, all patients will receive pegylated interferon alfa-2b (PegIFN-2b) and ribavirin according to European labeling; one cohort of participants will also be receiving substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin |
56; 150 | — |
| SECONDARY Number of Participants Who Achieved Sustained Virologic Response (SVR) |
42; 111 | — |
| SECONDARY Number of Participants Who Received Antiviral Treatment Who Were Also on Substitution Therapy |
90 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients with hepatitis C
Exclusion Criteria
- According to the products' European labeling
Data sourced from ClinicalTrials.gov (NCT00725751). 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.