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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic

Intervention: Pegylated interferon alfa-2b (PegIFN-2b) (Biological); Ribavirin (Drug)

Phase: N/A

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.


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).

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin

Secondary outcome:

Number of Participants Who Achieved Sustained Virologic Response (SVR)

Number of Participants Who Received Antiviral Treatment Who Were Also on Substitution Therapy


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Adult patients with hepatitis C

Exclusion Criteria:

- According to the products' European labeling

Locations and Contacts

Additional Information

Starting date: September 2007
Last updated: October 31, 2014

Page last updated: August 23, 2015

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