A Study of RO5024048 in Combination With Ritonavir-Boosted Danoprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C Genotype 1 Who Have Failed Prior HCV Protease Inhibitor Treatment

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01579019
First received: April 16, 2012
Last updated: August 26, 2014
Last verified: August 2014

April 16, 2012
August 26, 2014
July 2012
March 2014   (final data collection date for primary outcome measure)
Sustained virologic response (defined as unquantifiable serum HCV RNA) 12 weeks after treatment (SVR-12) [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01579019 on ClinicalTrials.gov Archive Site
  • Sustained virologic response 4 weeks after treatment (SVR-4) [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Sustained virologic response 24 weeks after treatment (SVR-24) [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Change in serum HCV RNA levels [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: No ]
  • Virologic response over time [ Time Frame: from baseline to 24 weeks after treatment ] [ Designated as safety issue: No ]
  • Correlation between trough concentrations of RO4995855 and virologic response [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Incidence of direct-acting antiviral (DAA) resistance, including re-emergence of protease inhibitor resistant virus [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of RO5024048 in Combination With Ritonavir-Boosted Danoprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C Genotype 1 Who Have Failed Prior HCV Protease Inhibitor Treatment
Not Provided

This randomized, double blind, phase II study will evaluate the efficacy and saf ety of two doses of RO5024048 in combination with ritonavir-boosted danoprevir a nd Pegasys (peginterferon alpha-2a) and Copegus (ribavirin) in patients who fail ed a prior protease inhibitor containing regimen with or without pegylated inter feron. Patients will be randomized to receive either a 2-week lead-in of RO50240 48 (1500 mg or 1000 mg orally twice daily) in combination with Pegasys (180 mcg subcutaneously weekly) and Copegus (1000 mg or 1200 mg orally daily) followed by 24 weeks of therapy with RO5024048 in combination with danoprevir (100 mg orall y twice daily) plus ritonavir (100 mg orally twice daily) and Pegasys and Copegu s (QUAD therapy), or 24 weeks of therapy with RO5024048 in combination with dano previr plus ritonavir and Pegasys and Copegus (QUAD therapy). Anticipated time o n study treatment is 24 or 26 weeks, with a treatment-free follow-up of 24 weeks

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
    1500 mg po bid, 24 or 26 weeks
  • Drug: RO5024048
    1000 mg po bid, 24 or 26 weeks
  • Drug: danoprevir
    100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26
  • Drug: peginterferon alfa-2a [Pegasys]
    180 mcg sc qw, 24 or 26 weeks
  • Drug: ribavirin [Copegus]
    1000 mg or 1200 mg po daily, 24 or 26 weeks
  • Drug: ritonavir
    100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26
  • Active Comparator: 1000 mg 24 weeks
    Interventions:
    • Drug: RO5024048
    • Drug: danoprevir
    • Drug: peginterferon alfa-2a [Pegasys]
    • Drug: ribavirin [Copegus]
  • Active Comparator: 1000 mg 26 weeks
    Interventions:
    • Drug: RO5024048
    • Drug: danoprevir
    • Drug: peginterferon alfa-2a [Pegasys]
    • Drug: ribavirin [Copegus]
    • Drug: ritonavir
  • Experimental: 1500 mg 24 weeks
    Interventions:
    • Drug: RO5024048
    • Drug: danoprevir
    • Drug: peginterferon alfa-2a [Pegasys]
    • Drug: ribavirin [Copegus]
    • Drug: ritonavir
  • Experimental: 1500 mg 26 weeks
    Interventions:
    • Drug: RO5024048
    • Drug: danoprevir
    • Drug: peginterferon alfa-2a [Pegasys]
    • Drug: ribavirin [Copegus]
    • Drug: ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Hepatitis C genotype 1 infection
  • Serum HCV quantifiable by Roche COBAS TaqMan HCV Test v2.0
  • Liver biopsy (within 24 months) or Fibroscan (within 12 months) before first administration of study drug consistent with chronic hepatitis C and demonstrating absence of liver cirrhosis
  • Documented failed prior treatment with protease inhibitor (evidenced by viral breakthrough or partial response while on treatment or relapse after treatment), including documentation on treatment with other direct-acting antiviral agents and other HCV antiviral treatment
  • Patients must have discontinued prior HCV treatment at least 24 weeks prior to first dose of study drug in this trial

Exclusion Criteria:

  • Infection with any HCV genotype other than genotype 1
  • Evidence of any variants associated with protease inhibitor resistance at screening
  • Body mass index (BMI) <18 or >/=36 kg/m2
  • Positive for hepatitis A or hepatitis B infection
  • Use of any systemic antiviral therapy with perceived activity against HCV </=1 month prior to first dose of study drug
  • History or evidence of a medical condition associated with chronic liver disease other than chronic hepatitis C
  • Pregnant or breastfeeding women
  • Males with female partners who are pregnant
  • History of immunologically mediated disease; patients with rheumatoid arthritis requiring only intermittent non-steroidal anti-inflammatory medications or with celiac disease will be allowed
  • History or evidence of decompensated liver disease
  • History or evidence of renal disease; patients with history of nephrolithiasis will be allowed
  • Uncontrolled Type 1 or 2 diabetes
  • History or evidence of chronic pulmonary disease associated with functional limitation
  • History of severe cardiac disease History of any neoplastic disease within the last 5 years, except for localized or in situ carcinoma of the skin (e.g. basal or squamous cell carcinoma)
  • Evidence of excessive alcohol, drug or substance abuse (excluding marijuana use) within 1 year of the first dose of study drug
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01579019
NV22877, 2010-022659-41
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

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