A Study of Ritonavir-Boosted Danoprevir (RO5190591) in Combination With Pegasys and Ribavirin in Patients With Chronic Hepatitis C Genotype 1

November 1, 2016 updated by: Hoffmann-La Roche

A Multiple-Dose Study To Evaluate Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Ritonavir-Boosted RO5190591 in Combination With Peginterferon Alfa-2a Plus Ribavirin in Patients With Chronic Hepatitis C Genotype 1

This study will evaluate the efficacy, safety and tolerability of danoprevir (RO5190591) plus ritonavir as compared to danoprevir alone or placebo plus ritonavir in patients with chronic hepatitis C genotype 1 receiving Pegasys (peginterferon alfa-2a) and ribavirin. Patients in cohorts will be randomized to receive either oral doses of danoprevir, or danoprevir plus ritonavir, or placebo plus ritonavir. All patients will receive Pegasys (180mcg sc once weekly) plus ribavirin (1000-1200mg/day po), with the option to continue this treatment after completion of study drug treatment. Anticipated time on study treatment is up to 12 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34094
  • New Zealand
      • Christchurch, New Zealand, 8011
      • Grafton, New Zealand, 1010
  • Poland
      • Warszawa, Poland, 01-201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults, 18-65 years of age
  • Chronic hepatitis C genotype 1
  • HCV treatment naïve, or without sustained virologic response on prior PEG-INF/RBV treatment
  • Body mass index (BMI) 18 - 35 kg/m2, inclusive; minimum weight 45 kg

Exclusion Criteria:

  • Liver cirrhosis
  • Decompensated liver disease or impaired liver function
  • Medical condition associated with chronic liver disease other than chronic hepatitis C
  • Positive for hepatitis B or HIV infection at screening
  • History of alcohol consumption exceeding 2 standard drinks per day when averaged over the course of a given week

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Drug: danoprevir
oral doses
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc once weekly
Drug: ribavirin
1000-1200mg/day po
Placebo Comparator: C
Drug: placebo
oral doses
Drug: ritonavir
oral doses
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc once weekly
Drug: ribavirin
1000-1200mg/day po
Experimental: B
Drug: ritonavir
oral doses
Drug: danoprevir
oral doses
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc once weekly
Drug: ribavirin
1000-1200mg/day po

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability: Adverse events, ECG, laboratory parameters
Time Frame: approximately 3 years
approximately 3 years
Pharmacokinetics: Cmax, AUC, Cmin, Tmax, Cl, T1/2
Time Frame: Days 3-9
Days 3-9
Antiviral activity: HCV RNA (COBAS Taqman HCV Test)
Time Frame: from baseline to Day 28
from baseline to Day 28

Secondary Outcome Measures

Outcome Measure
Time Frame
Viral resistance development
Time Frame: from baseline to Day 17
from baseline to Day 17
Effects on cytochrome P450(CYP)2C9 and 3A isozymes
Time Frame: from baseline to Day 17
from baseline to Day 17
Virological response in prior null-responders
Time Frame: from baseline to week 72
from baseline to week 72
Comparison of pharmacokinetics and antiviral activity between treatment-naïve patients and prior null-responders to standard of care treatment
Time Frame: approximately 3 years
approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

August 19, 2010

First Submitted That Met QC Criteria

August 19, 2010

First Posted (Estimate)

August 20, 2010

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP22660
  • 2009-012426-36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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