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

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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01770223

Enrollment

Registered

2013-01-17

Start date

2014-01-31

Completion date

2015-12-31

Last updated

2017-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

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).

Interventions

DRUGboceprevir

BIOLOGICALPegIFN-2b

DRUGRBV

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026