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

NCT00725751 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 353

Last updated 2015-10-02

Study results available
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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

BIOLOGICAL

Pegylated interferon alfa-2b (PegIFN-2b)

PegIFN-2b administered according to European labeling.

DRUG

Ribavirin

Ribavirin administered according to European labeling.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2011-03-31
Completion
2011-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00725751 on ClinicalTrials.gov