MedTrace Logo

A Study of Mericitabine in Combination With Boceprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C

NCT01482403 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2016-08-05

No results posted yet for this study

Summary

This randomized, double-blind, multi-center, placebo-controlled, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) in combination with boceprevir and Pegasys/Copegus in patients with chronic hepatitis C infection. The anticipated time on study treatment is up to 48 weeks.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

Copegus

total daily dose of 1000 mg or 1200 mg for 24 weeks

DRUG

Copegus

total daily dose of 1000 mg or 1200 mg for 48 weeks

DRUG

Pegasys

180 microgram subcutaneous once a week for 24 weeks

DRUG

Pegasys

180 microgram subcutaneous once a week for 48 weeks

DRUG

boceprevir

800 mg three times a day for 24 weeks

DRUG

boceprevir

800 mg three times a day for 48 weeks

DRUG

mericitabine

1000 mg twice daily for 24 weeks

DRUG

mericitabine placebo

mericitabine placebo

DRUG

boceprevir placebo

boceprevir placebo

DRUG

boceprevir

800 mg three times a day for 44 weeks

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

Countries

  • United States
  • Canada
  • France
  • Germany
  • Italy
  • Puerto Rico
  • Spain

Study Locations

More Related Trials

Entities

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 NCT01482403 on ClinicalTrials.gov