Study to Evaluate Different Regimens of Vaniprevir (MK7009) for the Treatment of Chronic Genotype 1 Hepatitis C Virus Infection in Treatment-naive Patients (MK-7009-019)(WITHDRAWN)

A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK7009 When Administered Concomitantly With Pegylated Interferon and Ribavirin in Treatment-Naive Patients With Chronic Genotype 1 Hepatitis C Virus Infection

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00895882

Enrollment

Registered

2009-05-08

Start date

2010-11-30

Completion date

2013-01-31

Last updated

2015-10-22

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

Conditions

Chronic Genotype 1 Hepatitis C Virus Infection

Brief summary

This study will evaluate the safety, tolerability, and efficacy of vaniprevir when administered concomitantly with pegylated interferon (peg-IFN) and ribavirin (RBV) to treat treatment-naive genotype 1 hepatitis C virus (HCV)-infected patients.

Interventions

DRUGvaniprevir (MK7009)

vaniprevir 300 mg soft gel capsules twice daily.

DRUGComparator: vaniprevir (MK7009)

vaniprevir 600 mg soft gel capsules twice daily.

DRUGComparator: Pegylated Interferon (peg-IFN) alfa-2a

Peg-IFN 180 mcg/0.5 mL subcutaneous injection once weekly

DRUGComparator: Ribavirin

Ribavirin, at a total daily dose of 1000 mg or 1200 mg based on patient weight, will be administered twice daily.

DRUGComparator: Placebo to vaniprevir

Placebo to vaniprevir soft gel capsules twice daily.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Patient has chronic genotype 1 HCV infection * Patient has had a liver biopsy without evidence of cirrhosis * Patient has had an eye exam prior to the start of study * Female patients capable of having children and male patients with female partners capable of having children agree to use two forms of birth control throughout the study

Exclusion criteria

* Patient has had previous treatment with: 3 or more doses IFN, peg-IFN, and/or RBV; and stopped treatment due to intolerance of one of the drugs; other antiviral or investigational therapies or vaccines for HCV * Female patient is pregnant or breastfeeding * Patient has chronic hepatitis not caused by HCV * Patient has evidence of cirrhosis of the liver * Patient has HIV * Patient has active hepatitis B infection * Patient has non-genotype 1 HCV infection * Patient consumes excessive amounts of alcohol

Design outcomes

Primary

Measure	Time frame
Proportion of patients achieving SVR24 in Treatment Regimens 1 to 4	24 weeks after end of study therapy
Evaluate the safety and tolerability of the MK7009 treatment regiments as assessed by review of the accumulated safety data	72 Weeks

Secondary

Measure	Time frame
1) Proportion of patients achieving SVR24 in Treatment Regimen 5	1) 24 weeks after end of study therapy

Outcome results

None listed

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