Skip to main content
OpenTrials
Completed

NCT Number: NCT01185860

A Study of Ritonavir-Boosted Danoprevir (RO5190591) in Combination With Pegasys and 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Montpellier, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Danoprevir

Drug

oral doses

peginterferon alfa-2a [Pegasys]

Drug

180 mcg sc once weekly

Placebo

Drug

oral doses

Ribavirin

Drug

1000-1200mg/day po

Ritonavir

Drug

oral doses

Primary outcomes

  1. Safety and tolerability: Adverse events, ECG, laboratory parameters

    Time frame: approximately 3 years

  2. Pharmacokinetics: Cmax, AUC, Cmin, Tmax, Cl, T1/2

    Time frame: Days 3-9

  3. Antiviral activity: HCV RNA (COBAS Taqman HCV Test)

    Time frame: from baseline to Day 28

Secondary outcomes

  1. Viral resistance development

    Time frame: from baseline to Day 17

  2. Effects on cytochrome P450(CYP)2C9 and 3A isozymes

    Time frame: from baseline to Day 17

  3. Virological response in prior null-responders

    Time frame: from baseline to week 72

  4. Comparison of pharmacokinetics and antiviral activity between treatment-naïve patients and prior null-responders to standard of care treatment

    Time frame: approximately 3 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 20, 2010
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.