Efficacy and Safety of Short Course Therapy With Peginterferon Alpha-2b (PEG-IFN Alfa-2b) and Ribavirin (RBV) for Chronic Hepatitis C (Genotype 4) Participants Achieving a Rapid Virological Response at Week 4 of Treatment (MK-8908B-059)

• Status: Terminated
• Trial end date: 2015-01-26
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy of a short course of therapy (24 weeks) versus standard 48 week treatment in previously untreated adult participants with chronic hepatitis C (CHC) genotype 4 infection who achieve rapid virologic response (RVR), defined as HCV ribonucleic acid (RNA) negativity after 4 weeks of treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Interferon alpha-2; Interferon-alpha; Peginterferon alfa-2b; Ribavirin

Criteria

Inclusion Criteria:

• Participant is ≥40 kg and ≤120 kg weight

• Participant and participant's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations.

• Previously documented CHC genotype 4 infection

• Liver biopsy or fibrotest and fibroscan with histology consistent with CHC and no other etiology and with hepatic fibrosis scores (F0, F1, F2, F3).

Exclusion Criteria:

• Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus

• Treatment for hepatitis C with any investigational medication

• Treatment with any investigational drug within 30 days of the screening visit

• Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy

• Autoimmune hepatitis or a history of autoimmune disease

• Hepatic fibrosis score F4

• Severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months

• Autoimmune hepatitis or a history of autoimmune disease

• Thyroid disease uncontrolled with conventional treatment

• Epilepsy and/or compromised central nervous system (CNS) function