NCT00725751

Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Participants With/Without Substitution Therapy (P05255)

Evaluation of Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Patients With/Without Substitution Therapy in Austria

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 353 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
BIOLOGICAL	Pegylated interferon alfa-2b (PegIFN-2b)	PegIFN-2b administered according to European labeling.
DRUG	Ribavirin	Ribavirin administered according to European labeling.

Timeline

• Start date: 2007-09-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2008-07-30
• Last updated: 2015-10-02
• Results posted: 2012-04-23