A Study of Viral Response to Triple Therapy in Hepatitis C Virus-Infected Participants With Insulin Resistance Who Failed Dual Therapy (MK-3034-113)
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|ClinicalTrials.gov Identifier: NCT01770223|
Recruitment Status : Withdrawn
First Posted : January 17, 2013
Last Update Posted : March 20, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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)|
|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|
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).
Other Name: SCH 503034
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 ]
Secondary Outcome Measures :
- Change from baseline in Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR) [ Time Frame: Baseline up to 8 weeks ]
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