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A Study of Danoprevir/Ritonavir and Copegus With RO5024048 and/or Pegasys in Patients With Chronic Hepatitis C

NCT01331850 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 381

Last updated 2016-11-02

No results posted yet for this study

Summary

This randomized, open-label, multi-center study will evaluate the sustained virological response, pharmacokinetics and safety of various combinations of danoprevir/ritonavir with Copegus plus RO5024048 and/or Pegasys in patients with chronic hepatitis C infection. Patients will be divided into 2 separate cohorts. Cohort A, previous partial responders, will be randomized to Groups 1-3 and cohort B, previous null responders, will be randomized to Groups 4-6. Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Groups 1 and 4 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Group 2 will receive Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Groups 3, 5 and 6 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus treatment.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

Copegus

1000 mg or 1200 mg daily oral doses for 24 weeks

DRUG

Copegus

1000 mg or 1200 mg daily oral doses for 48 weeks

DRUG

Pegasys

180 microgram subcutaneously once weekly for 24 weeks

DRUG

Pegasys

180 microgram subcutaneously once weekly for 48 weeks

DRUG

RO5024048

1000 mg oral doses twice a day for 24 weeks

DRUG

danoprevir

100 mg oral doses twice a day for 24 weeks

DRUG

ritonavir

100 mg oral doses twice a day for 24 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States
  • Australia
  • Austria
  • Brazil
  • Canada
  • France
  • Germany
  • Italy
  • Mexico
  • Poland
  • Puerto Rico
  • Spain
  • United Kingdom

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 NCT01331850 on ClinicalTrials.gov