- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01579019
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
November 1, 2016 updated by: Hoffmann-La Roche
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.
Study Overview
Status
Withdrawn
Conditions
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1000 mg 24 weeks
|
1500 mg po bid, 24 or 26 weeks
1000 mg po bid, 24 or 26 weeks
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
|
Active Comparator: 1000 mg 26 weeks
|
1500 mg po bid, 24 or 26 weeks
1000 mg po bid, 24 or 26 weeks
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
|
Experimental: 1500 mg 24 weeks
|
1500 mg po bid, 24 or 26 weeks
1000 mg po bid, 24 or 26 weeks
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
|
Experimental: 1500 mg 26 weeks
|
1500 mg po bid, 24 or 26 weeks
1000 mg po bid, 24 or 26 weeks
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sustained virologic response (defined as unquantifiable serum HCV RNA) 12 weeks after treatment (SVR-12)
Time Frame: approximately 2 years
|
approximately 2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety: Incidence of adverse events
Time Frame: approximately 2 years
|
approximately 2 years
|
Sustained virologic response 4 weeks after treatment (SVR-4)
Time Frame: approximately 2 years
|
approximately 2 years
|
Sustained virologic response 24 weeks after treatment (SVR-24)
Time Frame: approximately 2 years
|
approximately 2 years
|
Change in serum HCV RNA levels
Time Frame: from baseline to Week 12
|
from baseline to Week 12
|
Virologic response over time
Time Frame: from baseline to 24 weeks after treatment
|
from baseline to 24 weeks after treatment
|
Correlation between trough concentrations of RO4995855 and virologic response
Time Frame: approximately 2 years
|
approximately 2 years
|
Incidence of direct-acting antiviral (DAA) resistance, including re-emergence of protease inhibitor resistant virus
Time Frame: approximately 2 years
|
approximately 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Anticipated)
March 1, 2014
Study Completion (Anticipated)
March 1, 2014
Study Registration Dates
First Submitted
April 16, 2012
First Submitted That Met QC Criteria
April 16, 2012
First Posted (Estimate)
April 17, 2012
Study Record Updates
Last Update Posted (Estimate)
November 2, 2016
Last Update Submitted That Met QC Criteria
November 1, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis C, Chronic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Ribavirin
- Peginterferon alfa-2a
- Ritonavir
Other Study ID Numbers
- NV22877
- 2010-022659-41 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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