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
2 other identifiers
interventional
N/A
0 countries
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Brief Summary
This randomized, double blind, phase II study will evaluate the efficacy and safety of two doses of RO5024048 in combination with ritonavir-boosted danoprevir and Pegasys (peginterferon alpha-2a) and Copegus (ribavirin) in patients who failed a prior protease inhibitor containing regimen with or without pegylated interferon. Patients will be randomized to receive either a 2-week lead-in of RO5024048 (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 orally twice daily) plus ritonavir (100 mg orally twice daily) and Pegasys and Copegus (QUAD therapy), or 24 weeks of therapy with RO5024048 in combination with danoprevir plus ritonavir and Pegasys and Copegus (QUAD therapy). Anticipated time on study treatment is 24 or 26 weeks, with a treatment-free follow-up of 24 weeks.
Trial Health
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Started Jul 2012
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2012
CompletedFirst Posted
Study publicly available on registry
April 17, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedNovember 2, 2016
November 1, 2016
1.7 years
April 16, 2012
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Sustained virologic response (defined as unquantifiable serum HCV RNA) 12 weeks after treatment (SVR-12)
approximately 2 years
Secondary Outcomes (7)
Sustained virologic response 4 weeks after treatment (SVR-4)
approximately 2 years
Sustained virologic response 24 weeks after treatment (SVR-24)
approximately 2 years
Change in serum HCV RNA levels
from baseline to Week 12
Virologic response over time
from baseline to 24 weeks after treatment
Correlation between trough concentrations of RO4995855 and virologic response
approximately 2 years
- +2 more secondary outcomes
Study Arms (4)
1000 mg 24 weeks
ACTIVE COMPARATOR1000 mg 26 weeks
ACTIVE COMPARATOR1500 mg 24 weeks
EXPERIMENTAL1500 mg 26 weeks
EXPERIMENTALInterventions
100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26
180 mcg sc qw, 24 or 26 weeks
1000 mg or 1200 mg po daily, 24 or 26 weeks
100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2012
First Posted
April 17, 2012
Study Start
July 1, 2012
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
November 2, 2016
Record last verified: 2016-11