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A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C

A Phase II, Randomized, Double-Blind, Multicenter, Parallel Group Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug RO5024048 in Combination With Telaprevir and Pegasys®/Copegus® in Patients With Chronic Hepatitis C Genotype 1 Virus Infection Who Were Prior Null Responders to Treatment With Pegylated Interferon/Ribavirin

NCT01482390•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This randomized, double-blind, multi-center, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) (MCB) in combination with telaprevir (TVR) and peginterferon Alfa-2a (PEG-IFN) / ribavirin (RBV) in participants with chronic Hepatitis C infection.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Chronic hepatitis C infection for at least 6 months duration
•Hepatitis C genotype 1a or 1b
•Participants must have discontinued prior hepatitis C treatment at least 12 weeks prior to enrollment in this study
•Participants showed a previous null response to therapy as defined by \< 2 logarithm to the base 10 (log10) international units per milliliter (IU/mL) decrease in viral titer after at least 12 weeks of treatment with PEG-IFN/RBV

Exclusion Criteria

•Hepatitis C infection with a genotype other than genotype 1a or 1b
•Body mass index \< 18 or \>= 36 kilograms per square meters (kg/m\^2)
•Hepatitis A, hepatitis B, or human immunodeficiency virus (HIV) infection
•Herbal remedies \<=1 month prior to the first dose of study drug

Locations (39)

Birmingham Gastro Associates, P.C.

Birmingham, Alabama, United States

VA Long Beach Healthcare System

Long Beach, California, United States

Kaiser Permanente Sacramento Medical Center

Sacramento, California, United States

UCSD Antiviral Research Center

San Diego, California, United States

Yale University

New Haven, Connecticut, United States

Gastroenterology Group of Naples

Naples, Florida, United States

John Hopkins Hospital

Lutherville, Maryland, United States

Metrowest Medical Center

Framingham, Massachusetts, United States

Saint Louis University Gastroenterology & Hepatology; Clinical Research Unit

St Louis, Missouri, United States

Weill Cornell Medical College

New York, New York, United States

Key Dates

Start Date

November 30, 2011

Primary Completion Date

January 31, 2014

Completion Date

January 31, 2014

Last Updated

April 24, 2017

Enrollment

ACTUAL participants

Conditions

Hepatitis C

Interventions

Ribavirin

DRUG

Mericitabine

DRUG

Peginterferon Alfa-2a

DRUG

Placebo

DRUG

Telaprevir

DRUG

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RECRUITINGNA

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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: April 24, 2017Data 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.

View ClinicalTrials.gov Terms and Conditions

A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C

Inclusion Criteria

Exclusion Criteria

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