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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01483742
First received: November 30, 2011
Last updated: July 28, 2016
Last verified: July 2016
History of Changes
November 30, 2011
July 28, 2016
April 2012
September 2013   (Final data collection date for primary outcome measure)
  • Safety: Incidence of adverse events [ Time Frame: 48 weeks ]
  • Pharmacokinetics (PK): 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 ]
  • Antiviral activity: Hepatitis C virus (HCV) RNA levels assessed by Roche COBAS Taqman HCV Test [ Time Frame: 48 weeks ]
  • Safety: Incidence of adverse events [ Time Frame: 48 weeks ]
  • 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 ]
  • Antiviral activity: HCV RNA levels assessed by Roche COBAS Taqman HCV Test [ Time Frame: 48 weeks ]
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 ]
  • Virologic response: HCV RNA levels [ Time Frame: approximately 1 year ]
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
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: RO5024048
    1000 mg orally bid, 24 weeks
  • Drug: danoprevir
    100 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
  • Drug: ritonavir
    100 mg orally bid, 24 weeks
  • Experimental: Combination without RO5024048
    Ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients
    Interventions:
    • Drug: danoprevir
    • Drug: peginterferon alfa-2a [Pegasys]
    • Drug: ribavirin
    • Drug: ritonavir
  • Experimental: Combination with RO5024048
    RO5024048 added to the combination treatment (ritonavir-boosted danoprevir in combination with Pegasys [peginterferon alfa-2a] and ribavirin) in prior null responder patients
    Interventions:
    • Drug: RO5024048
    • Drug: danoprevir
    • Drug: peginterferon alfa-2a [Pegasys]
    • Drug: ribavirin
    • Drug: ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
September 2013
September 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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   France,   New Zealand,   Poland,   Slovakia,   United States
 
 
NCT01483742
NP27946
2011-004129-28 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2016

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