A Study of RO5024048 in Combination With Ritonavir-Boosted Danoprevir With or Without Copegus (Ribavirin) in Interferon-Naïve Patients With Chronic Hepatitis C Genotype 1 (INFORM-SVR)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01278134
First received: January 14, 2011
Last updated: March 25, 2013
Last verified: March 2013

January 14, 2011
March 25, 2013
February 2011
March 2013   (final data collection date for primary outcome measure)
  • Sustained virological response, defined as undetectable HVC RNA measured by Roche COBAS TaqMan HCV test [ Time Frame: 24 weeks after end of treatment ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01278134 on ClinicalTrials.gov Archive Site
  • Virological response (HCV RNA measured by Roche COBAS Taqman HCV test) [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • Impact of Copegus (ribavirin) on efficacy of the direct-acting antiviral combination regimen: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test) [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Comparison of 12 and 24 weeks of treatment duration: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test) [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Plasma concentrations of danoprevir, ritonavir, RO4995855 (parent drug of RO5024048) and ribavirin [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • Viral resistance: HCV RNA sequencing and phenotypic analyses [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • Effect of interleukin 28B genotype on efficacy: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test) [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Quality of life: SF-36 questionnaire, Fatigue Severity Scale [ Time Frame: up to 36 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of RO5024048 in Combination With Ritonavir-Boosted Danoprevir With or Without Copegus (Ribavirin) in Interferon-Naïve Patients With Chronic Hepatitis C Genotype 1 (INFORM-SVR)
INFORM-SVR: A Randomized, Multi-Center Study of Interferon-Free Treatment With a Combination of a Polymerase Inhibitor (RO5024048) and a Ritonavir Boosted HCV Protease Inhibitor (RO5190591/r, DNV/r) With or Without Copegus® in Interferon Naïve HCV Genotype 1 Infected Patients

This multicenter, randomized, double-blind, parallel group study will evaluate the safety and efficacy of the combination RO5024048 and ritonavir-boosted danoprevir with and without Copegus (ribavirin) in patients with chronic hepatitis C genotype 1. In arm A and B, interferon treatment-naïve patients will receive 1000 mg RO5024048 orally twice daily and 100 mg danoprevir with 100 mg ritonavir orally twice daily plus either Copegus (1000 mg or 1200 mg orally daily) or placebo for 12 weeks. Depending on viral response and treatment arm patients will be re-randomized to continue assigned treatment for additional 12 weeks or stop all treatment. The anticipated time on study treatment is up to 24 weeks plus a 24-week follow-up.

As of 29. September 2011, Arm B patients (placebo-containing arm) will be offered, in conjunction with the current treatment, Pegasys (peginterferon alfa-2a) 180 mcg subcutaneously weekly plus Copegus 1000mg or 1200 mg orally daily for 24 weeks, with a 24-week follow-up.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: RO5024048
    1000 mg bid orally, up to 24 weeks
  • Drug: danoprevir
    100 mg bid orally, up to 24 weeks
  • Drug: ritonavir
    100 mg bid orally, up to 24 weeks
  • Drug: ribavirin [Copegus]
    1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks
  • Drug: Copegus placebo
    1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks
  • Drug: peginterferon alfa-2a [Pegasys]
    180 mcg sc weekly, 24 weeks
  • Experimental: A
    Interventions:
    • Drug: RO5024048
    • Drug: danoprevir
    • Drug: ritonavir
    • Drug: ribavirin [Copegus]
  • Experimental: B
    Interventions:
    • Drug: RO5024048
    • Drug: danoprevir
    • Drug: ritonavir
    • Drug: Copegus placebo
  • Experimental: B extension
    All patients in treatment arm B were offered to receive Pegasys/Cogepus therapy for an additional 24 weeks.
    Interventions:
    • Drug: ribavirin [Copegus]
    • Drug: peginterferon alfa-2a [Pegasys]
Tong X, Li L, Haines K, Najera I. Identification of the NS5B S282T resistant variant and two novel amino acid substitutions that affect replication capacity in hepatitis C virus-infected patients treated with mericitabine and danoprevir. Antimicrob Agents Chemother. 2014 Jun;58(6):3105-14. doi: 10.1128/AAC.02672-13. Epub 2014 Mar 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
170
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patient, >/= 18 years of age
  • Chronic Hepatitis C of >/= 6 months duration at screening
  • HCV genotype 1 and quantifiable HCV RNA at screening (Roche COBAS TaqMan HCV test)
  • Naïve for treatment with interferon (pegylated or non-pegylated)
  • Body Mass Index (BMI) 18-35 inclusive, minimum weight 45 kg
  • Females of child-bearing potential and males with female partners of childbearing potential must use 2 forms of effective non-hormonal contraception

Exclusion Criteria:

  • Pregnant or lactating women and males with female partners who are pregnant or lactating
  • Decompensated liver disease or impaired liver function
  • Cirrhosis or incomplete/transition to cirrhosis
  • Non-hepatitis C chronic liver disease
  • Hepatitis B or HIV infection
  • History of neoplastic disease within the last 5 years, except for localized or in situ carcinoma of the skin
  • History of pre-existing renal disease (except for nephrolithiasis) or severe cardiac disease
  • History of drug or alcohol abuse within the last year or alcohol consumption of > 2 units per day; cannabinoid use is excepted
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   New Zealand,   France,   Germany
 
NCT01278134
PP25213, 2010-022067-35
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
March 2013

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