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)
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: PEG-IFN alfa-2b (Drug); ribavirin (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Merck Sharp & Dohme Corp.
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.
Clinical Details
Official title: Randomized Open Label Study to Assess the Efficacy and Safety of Short Course Therapy (24 Weeks) With Peginterferon Alpha-2b and Ribavirin for Chronic Hepatitis C (Genotype 4) Patients Who Achieve a Rapid Virological Response (HCV -RNA Undetectable at Week 4 of Treatment)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Participants Achieving Sustained Virologic Response (SVR)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: January 2013
Last updated: June 23, 2015
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