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

Sponsor

Merck Sharp & Dohme LLC (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01770223

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

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 :

Jan 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

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 Names: SCH 503034 Biological: PegIFN-2b Other Names: Peginterferon alfa-2b PegIntron SCH 054031 Drug: RBV Other Names: Ribavirin Rebetol

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 Names:

SCH 503034

Biological: PegIFN-2b

Other Names:

Peginterferon alfa-2b

PegIntron

SCH 054031

Drug: RBV

Other Names:

Ribavirin

Rebetol

Outcome Measures

Primary Outcome Measures

Number of participants with sustained virologic response (SVR) at 24 weeks after the end of 48 weeks of study treatment [Week 72]

Secondary Outcome Measures

Change from baseline in Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR) [Baseline up to 8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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