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
NCT ID: NCT01579019
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2012-07-31
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PARALLEL
TREATMENT
DOUBLE
Study Groups
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1000 mg 24 weeks
RO5024048
1000 mg po bid, 24 or 26 weeks
danoprevir
100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26
peginterferon alfa-2a [Pegasys]
180 mcg sc qw, 24 or 26 weeks
ribavirin [Copegus]
1000 mg or 1200 mg po daily, 24 or 26 weeks
1000 mg 26 weeks
RO5024048
1000 mg po bid, 24 or 26 weeks
danoprevir
100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26
peginterferon alfa-2a [Pegasys]
180 mcg sc qw, 24 or 26 weeks
ribavirin [Copegus]
1000 mg or 1200 mg po daily, 24 or 26 weeks
ritonavir
100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26
1500 mg 24 weeks
RO5024048
1500 mg po bid, 24 or 26 weeks
danoprevir
100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26
peginterferon alfa-2a [Pegasys]
180 mcg sc qw, 24 or 26 weeks
ribavirin [Copegus]
1000 mg or 1200 mg po daily, 24 or 26 weeks
ritonavir
100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26
1500 mg 26 weeks
RO5024048
1500 mg po bid, 24 or 26 weeks
danoprevir
100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26
peginterferon alfa-2a [Pegasys]
180 mcg sc qw, 24 or 26 weeks
ribavirin [Copegus]
1000 mg or 1200 mg po daily, 24 or 26 weeks
ritonavir
100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26
Interventions
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RO5024048
1500 mg po bid, 24 or 26 weeks
RO5024048
1000 mg po bid, 24 or 26 weeks
danoprevir
100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26
peginterferon alfa-2a [Pegasys]
180 mcg sc qw, 24 or 26 weeks
ribavirin [Copegus]
1000 mg or 1200 mg po daily, 24 or 26 weeks
ritonavir
100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Countries
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Other Identifiers
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2010-022659-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NV22877
Identifier Type: -
Identifier Source: org_study_id