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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)

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ClinicalTrials.gov Identifier: NCT01606800
Recruitment Status : Terminated (The trial was terminated due to change in new standard of therapy during the study period.)
First Posted : May 28, 2012
Results First Posted : February 23, 2016
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: PEG-IFN alfa-2b Drug: ribavirin Phase 4

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  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01606800


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01606800     History of Changes
Other Study ID Numbers: 8908B-059
MK-8908B-059 ( Other Identifier: Merck Registration Number )
First Posted: May 28, 2012    Key Record Dates
Results First Posted: February 23, 2016
Last Update Posted: April 10, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Interferon-alpha
Peginterferon alfa-2b
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs