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

NCT ID: NCT01770223

Last Updated: 2017-03-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-12-31

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).

Conditions

Hepatitis C

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

boceprevir

Intervention Type: DRUG

PegIFN-2b

Intervention Type: BIOLOGICAL

RBV

Intervention Type: DRUG

Interventions

boceprevir

Intervention Type: DRUG

PegIFN-2b

Intervention Type: BIOLOGICAL

RBV

Intervention Type: DRUG

Other Intervention Names

SCH 503034; Peginterferon alfa-2b; PegIntron; SCH 054031; Ribavirin; Rebetol

Eligibility 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

• 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

Other Identifiers

2012-002771-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

3034-113

Identifier Type: -

Identifier Source: org_study_id