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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(MK7009) for the Treatment of Chronic Genotype 1 Hepatitis C Virus Infection in Treatment-naive Patients (MK-7009-019)(WITHDRAWN)

NCT00895882 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-10-22

No results posted yet for this study

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.

Conditions

  • Chronic Genotype 1 Hepatitis C Virus Infection

Interventions

DRUG

vaniprevir (MK7009)

vaniprevir 300 mg soft gel capsules twice daily.

DRUG

Comparator: vaniprevir (MK7009)

vaniprevir 600 mg soft gel capsules twice daily.

DRUG

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

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

DRUG

Comparator: Ribavirin

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

DRUG

Comparator: Placebo to vaniprevir

Placebo to vaniprevir soft gel capsules twice daily.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2013-01-31
Completion
2013-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00895882 on ClinicalTrials.gov