A Study of Ritonavir-Boosted Danoprevir and RO5024048 in Different Combinations in Null Responder or Treatment-Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01483742
First received: November 30, 2011
Last updated: May 7, 2013
Last verified: May 2013

November 30, 2011
May 7, 2013
April 2012
October 2013   (final data collection date for primary outcome measure)
  • Safety: Incidence of adverse events [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: Intensive PK sample collection during initial 2 week dosing period, followed by routine sampling during treatment up to Week 24 ] [ Designated as safety issue: No ]
  • Antiviral activity: HCV RNA levels assessed by Roche COBAS Taqman HCV Test [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01483742 on ClinicalTrials.gov Archive Site
  • Emergence of viral resistance: HCV RNA gene sequence variations [ Time Frame: From baseline to Week 48 ] [ Designated as safety issue: No ]
  • Virologic response: HCV RNA levels [ Time Frame: approximately 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Ritonavir-Boosted Danoprevir and RO5024048 in Different Combinations in Null Responder or Treatment-Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Ritonavir-Boosted DANOPREVIR and RO5024048 in Different Combinations in Null Responder or Treatment Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis

This open-label, parallel cohort study will evaluate the safety, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients, and with RO5024048 added to the combination treatment in prior null responder patients with chronic hepatitis C genotype 1 or 4 and compensated cirrhosis. All patients will receive danoprevir 100 mg orally twice daily (bid) , ritonavir 100 mg orally bid, Pegasys 180 mcg subcutaneously weekly and ribavirin 1000-1200 mg/kg/day orally. Prior non-responders will receive RO5024048 1000 mg orally bid additionally. Anticipated time on study treatment is 24 weeks.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: danoprevir
    100 mg orally bid, 24 weeks
  • Drug: ritonavir
    100 mg orally bid, 24 weeks
  • Drug: RO5024048
    1000 mg orally bid, 24 weeks
  • Drug: peginterferon alfa-2a [Pegasys]
    180 mcg weekly, 24 weeks
  • Drug: ribavirin
    1000-1200 mg/kg/day orally in two divided doses, 24 weeks
  • Experimental: 1 Treatment-naïve
    Interventions:
    • Drug: danoprevir
    • Drug: ritonavir
    • Drug: peginterferon alfa-2a [Pegasys]
    • Drug: ribavirin
  • Experimental: 2 Prior null responders
    Interventions:
    • Drug: danoprevir
    • Drug: ritonavir
    • Drug: RO5024048
    • Drug: peginterferon alfa-2a [Pegasys]
    • Drug: ribavirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
43
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, 18 to 65 years of age inclusive
  • Chronic hepatitis C, genotype 1 or 4
  • Cohort 1: Treatment-naïve for hepatitis C
  • Cohort 2: Prior null responder to treatment with approved doses of pegylated interferon plus ribavirin
  • Liver biopsy confirming cirrhosis
  • Compensated cirrhosis (Child-Pugh A)

Exclusion Criteria:

  • Pregnant or lactating women or male partners of women who are pregnant
  • History or presence of decompensated liver disease (ascites, hepatic encephalopathy, hepatocellular carcinoma, or bleeding esophageal varices)
  • Cohort 2: Patients who discontinued previous pegylated interferon plus ribavirin treatment due to reasons other than null response
  • History of clinically significant cardiovascular or cerebrovascular disease
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   France,   New Zealand,   Poland,   Slovakia
 
NCT01483742
NP27946, 2011-004129-28
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP