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

NCT01482390 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-04-24

No results posted yet for this study

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.

Conditions

  • Hepatitis C

Interventions

DRUG

Ribavirin

Participants will receive a total daily dose of 1000 milligrams (mg) (for participants weighing less than \[\<\] 75 kg) or 1200 mg (for participants weighing greater than or equal to \[\>=\] 75 kg) orally for 24 or 48 weeks.

DRUG

Mericitabine

Participants will receive mericitabine 1000 mg orally twice daily.

DRUG

Peginterferon Alfa-2a

Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.

DRUG

Placebo

Participants will receive placebo matching to mericitabine orally twice daily.

DRUG

Telaprevir

Participants will receive telaprevir 750 mg orally three times daily.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-01-31
Completion
2014-01-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT01482390 on ClinicalTrials.gov