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

• Status: Withdrawn
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Peginterferon alfa-2b; Ribavirin

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