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A Study of Danoprevir Boosted With Low Dose Ritonavir in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Virus Infection

NCT01220947 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 421

Last updated 2016-11-02

No results posted yet for this study

Summary

This randomized, open-label, active-controlled, parallel-group study will evaluate the sustained virological response of danoprevir boosted with low dose ritonavir in combination with Pegasys (peginterferon alfa-2a) and Copegus versus Pegasys and Copegus alone in treatment-naive patients with chronic Hepatitis C.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

Copegus

Copegus 1000 mg or 1200 mg po daily for 24 weeks.

DRUG

Danoprevir

Danoprevir 50 mg BID

DRUG

Danoprevir

Danoprevir 100 mg BID

DRUG

Danoprevir

Danoprevir 200 mg BID

DRUG

Pegasys

Pegasys 180 microgram sc qw

DRUG

Ritonavir

Ritonavir 100 mg

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
2010-11-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States
  • Austria
  • Brazil
  • Canada
  • France
  • Germany
  • Italy
  • Mexico
  • 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 NCT01220947 on ClinicalTrials.gov