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) (START 4)

September 27, 2018 updated by: Merck Sharp & Dohme LLC

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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
Experimental: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Achieving Sustained Virologic Response (SVR)
Time Frame: At 24 weeks after the completion of therapy (up to 72 weeks)
SVR was defined as undetectable HCV RNA levels 24 weeks after the completion of therapy.
At 24 weeks after the completion of therapy (up to 72 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

January 26, 2015

Study Completion (Actual)

January 26, 2015

Study Registration Dates

First Submitted

May 24, 2012

First Submitted That Met QC Criteria

May 24, 2012

First Posted (Estimate)

May 28, 2012

Study Record Updates

Last Update Posted (Actual)

October 25, 2018

Last Update Submitted That Met QC Criteria

September 27, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8908B-059
  • MK-8908B-059 (Other Identifier: Merck Registration Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Study Data/Documents

  1. CSR Synopsis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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