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)

NCT ID: NCT01606800

Last Updated: 2018-10-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-01
• Study Completion Date: 2015-01-26

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

44 Weeks of PEG-IFN alfa-2b + RBV

Participants achieving RVR at 4 weeks of treatment will receive 44 additional weeks of Peg-IFN Alfa-2b + RBV.

Group Type: EXPERIMENTAL

PEG-IFN alfa-2b

Intervention Type: DRUG

Pegylated interferon alfa-2b administered subcutaneously 1.5 mcg/kg/week

ribavirin

Intervention Type: DRUG

Ribavirin 200 mg capsules administered orally daily based on weight

20 Weeks of PEG-IFN alfa-2b + RBV

Participants achieving RVR at 4 weeks of treatment will receive 20 additional weeks of Peg-IFN Alfa-2b + RBV.

Group Type: EXPERIMENTAL

PEG-IFN alfa-2b

Intervention Type: DRUG

Pegylated interferon alfa-2b administered subcutaneously 1.5 mcg/kg/week

ribavirin

Intervention Type: DRUG

Ribavirin 200 mg capsules administered orally daily based on weight

Interventions

PEG-IFN alfa-2b

Pegylated interferon alfa-2b administered subcutaneously 1.5 mcg/kg/week

Intervention Type: DRUG

ribavirin

Ribavirin 200 mg capsules administered orally daily based on weight

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

MK-8908B-059

Identifier Type: OTHER

Identifier Source: secondary_id

8908B-059

Identifier Type: -

Identifier Source: org_study_id