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Study of Vaniprevir Plus PegIntron®/Ribavirin in Japanese Participants With Chronic Hepatitis C Who Relapsed After Treatment (MK-7009-044) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study of Vaniprevir Plus PegIntron®/Ribavirin in Japanese Participants With Chronic Hepatitis C Who Relapsed After Treatment (MK-7009-044)

A Phase III Study to Evaluate the Safety, Tolerability, and Efficacy of MK-7009 When Concomitantly Administered With Peginterferon Alfa-2b and Ribavirin in Japanese Patients With Chronic Hepatitis C Infection Who Relapsed After Previous Treatment

NCT01405937•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir given in combination with pegylated interferon alfa-2b (PegIntron®/peg-IFN) and ribavirin (RBV) in chronic hepatitis C (CHC) Genotype I (GT 1) participants who relapsed after previous therapy with interferon-based therapy. The primary efficacy hypothesis is that the percentage of participants achieving sustained virologic response 24 weeks after completion of all study therapy (SVR24) in at least one of the vaniprevir 300 mg twice daily treatment regimens is greater than 20% (historical data of standard of care treatment).

Eligibility

Age

20 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Japanese participant diagnosed with compensated CHC GT 1
•Absence of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease
•Has received and tolerated treatment with IFN-based therapy (IFN α, IFN β, or peg-IFN) with or without use of ribavirin, but failed to respond to the prior treatment (relapse or breakthrough)
•No evidence of cirrhosis

Exclusion Criteria

•Co-infection with human immunodeficiency virus (HIV)
•Positive hepatitis B surface antigen or other evidence of active hepatitis B infection
•Any other condition that is contraindicated or for which caution is required for treatment with peg-IFN or RBV
•Any condition or pre-study laboratory abnormality, or history of any illness, that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs, peg-IFN and RBV, to the participant

Key Dates

Start Date

August 29, 2011

Primary Completion Date

February 26, 2013

Completion Date

March 12, 2013

Last Updated

October 18, 2018

Enrollment

ACTUAL participants

Conditions

Hepatitis C, Chronic

Interventions

vaniprevir

DRUG

peg-IFN

BIOLOGICAL

ribavirin

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 18, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Vaniprevir Plus PegIntron®/Ribavirin in Japanese Participants With Chronic Hepatitis C Who Relapsed After Treatment (MK-7009-044)

Inclusion Criteria

Exclusion Criteria

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study

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The Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection