A Study of Viral Response to Triple Therapy in Hepatitis C Virus-Infected Participants With Insulin Resistance Who Failed Dual Therapy (MK-3034-113)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01770223
Recruitment Status : Withdrawn
First Posted : January 17, 2013
Last Update Posted : March 20, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This study is being done to find out if participants with insulin resistance and hepatitis C virus genotype 1 (HCV GT1) infections who failed dual therapy with peginterferon alfa (PegIFN) + ribavirin (RBV) will benefit from the addition of boceprevir to PegIFN + RBV (triple therapy).

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: boceprevir Biological: PegIFN-2b Drug: RBV Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study Assessing SVR and Viral Resistance Profile With Boceprevir Plus PEG-IFN Plus Ribavirin Triple Therapy in HCV-1 Infected Patients With Insulin Resistance Who Have Failed PEG-IFN Plus Ribavirin Dual Therapy
Study Start Date : January 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Boceprevir

Arm Intervention/treatment
Experimental: Boceprevir + PegIFN-2b + RBV
All participants will start treatment with 4 weeks of PegIFN-2b subcutaneously, 1.5μg/kg per week + RBV capsules orally, at a weight-based dose between 800-1400 mg/day divided into two daily doses (double therapy). Participants without cirrhosis will then continue on the PegIFN-2b and RBV with the addition of boceprevir capsules orally, 800 mg three times per day for 32 weeks (triple therapy), and will transition back to double therapy for the final 12 weeks of treatment (48 total weeks of therapy). Participants with cirrhosis or documented as null responders will receive triple therapy for 44 weeks (48 total weeks of therapy).
Drug: boceprevir
Other Name: SCH 503034

Biological: PegIFN-2b
Other Names:
  • Peginterferon alfa-2b
  • PegIntron
  • SCH 054031

Drug: RBV
Other Names:
  • Ribavirin
  • Rebetol

Primary Outcome Measures :
  1. Number of participants with sustained virologic response (SVR) at 24 weeks after the end of 48 weeks of study treatment [ Time Frame: Week 72 ]

Secondary Outcome Measures :
  1. Change from baseline in Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR) [ Time Frame: Baseline up to 8 weeks ]

Information from the National Library of Medicine

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

Inclusion criteria:

  • Quantifiable serum hepatitis C virus-ribonucleic acid (HCV-RNA)
  • Hepatitis C virus genotype 1
  • Homeostasis Model of Assessment - Insulin Resistance (HOMA IR) > 2.5 in two determinations made 4 weeks apart (the first HOMA evaluation is able to be made 3 weeks before screening visit)
  • Previous failure to achieve SVR with PegIFN plus ribavirin given for a minimum of 12 weeks without dose reduction below 80% of the adequate doses of the two drugs
  • No response, partial response, or relapse after previous therapy
  • Compensated liver disease with or without histologic or non-invasive evidence of liver cirrhosis
  • If heterosexually active, a female participant of childbearing potential and a non-vasectomized male participant who has a female partner of childbearing potential must agree to use 2 effective contraceptives until 6 months after therapy has ended (7 months for male subject)

Exclusion criteria:

  • Coinfection with HCV genotypes other than HCV-GT1
  • Evidence of decompensated liver disease
  • History of ascites, hepatic encephalopathy or of bleeding varices or severe portal hypertension
  • History or signs or symptoms or evidence of hepatocellular carcinoma (HCC)
  • History of organ transplant
  • Coinfection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Severe psychiatric disease
  • Inadequately controlled thyroid function
  • Other important comorbidities (cardiovascular diseases, Type 1 diabetes or inadequately controlled type 2 diabetes, malignancies , etc)
  • Substances abuse
  • Alcohol intake >20 grams/day for females and >30 grams/day for males
  • History of severe adverse events during previous treatment with PegIFN plus ribavirin including discontinuation of therapy for severe anemia or hematologic toxicity

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01770223     History of Changes
Other Study ID Numbers: 3034-113
2012-002771-33 ( EudraCT Number )
First Posted: January 17, 2013    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Hepatitis C
Insulin Resistance
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Glucose Metabolism Disorders
Metabolic Diseases
Peginterferon alfa-2b
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents