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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01770223
First received: January 15, 2013
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Hepatitis C
Drug: boceprevir
Biological: PegIFN-2b
Drug: RBV
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of participants with sustained virologic response (SVR) at 24 weeks after the end of 48 weeks of study treatment [ Time Frame: Week 72 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR) [ Time Frame: Baseline up to 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01770223     History of Changes
Other Study ID Numbers: 3034-113, 2012-002771-33
Study First Received: January 15, 2013
Last Updated: December 23, 2013
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Insulin Resistance
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ribavirin
Peginterferon alfa-2b
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014