NCT01606800

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)

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)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants who achieved RVR after 4 weeks of PEG-INF alfa-2b plus RBV treatment were randomized to receive either 20 or 44 weeks of continued therapy, for a total of 24 or 48 weeks total of PEG-INF plus RBV therapy.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	PEG-IFN alfa-2b	Pegylated interferon alfa-2b administered subcutaneously 1.5 mcg/kg/week
DRUG	ribavirin	Ribavirin 200 mg capsules administered orally daily based on weight

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-01-26
• Completion: 2015-01-26
• First posted: 2012-05-28
• Last updated: 2018-10-25
• Results posted: 2016-02-23