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This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: January 15, 2013
Last updated: November 24, 2014
Last verified: November 2014
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).
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
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 ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2015 (Final data collection date for primary outcome measure)
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
- Peginterferon alfa-2b
- SCH 054031
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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)
- 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
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No publications provided
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 15, 2013
||November 24, 2014
||Italy: Ethics Committee
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 03, 2015
Glucose Metabolism Disorders