Clinical trial NCT01770223: A Study of Viral Response to Triple Therapy in Hepatitis C Virus-Infected Participants With Insulin Resistance Who Failed Dual Therapy (MK-3034-113)
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2013-01-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Number of participants with sustained virologic response (SVR) at 24 weeks after the end of 48 weeks of study treatment
timeFrame: Week 72
Secondary outcomes:
measure: Change from baseline in Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR)
timeFrame: Baseline up to 8 weeks
Other outcomes:
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