- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01903954
A Study of Setrobuvir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Genotype 1 Chronic Hepatitis C
November 1, 2016 updated by: Hoffmann-La Roche
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of ANA598 Administered With Pegylated Interferon and Ribavirin in Genotype 1 Patients With Chronic Hepatitis C Infection
This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of setrobuvir in patients with genotype 1 chronic hepatitis C. Treatment-naïve patients will be randomized to receive either setrobuvir (800 mg orally b.i.d loading dose followed by 200 mg orally .b.i.d.) or placebo in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin).
Treatment duration will be 28 weeks or 48 weeks depending on response.
Treatment-experienced patients categorized as relapsers, partial responders and viral breakthrough patients to previous pegylated interferon and ribavirin therapy will be randomized to receive either setrobuvir or placebo in combination with Pegasys and Copegus for 48 weeks.
Treatment-experienced patients categorized as null-responders to previous pegylated interferon and ribavirin therapy will be assigned to treatment with setrobuvir plus Pegasys and Copegus for 48 weeks.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
283
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients, 18 to 65 years of age inclusive
- Documented chronic hepatitis C
- Treatment-naïve (no prior exposure to Pegasys, Copegus, or experimental HCV therapy) or treatment-experienced with current standard of care (Pegasys and Copegus) but categorized as null-responder or patients with partial response, relapse or viral breakthrough during or following prior treatment
- Serum HCV RNA >/= 50,000 IU/mL at screening
- HCV antibody positive at screening
- HCV genotype 1
- Body mass index (BMI) 18-38 kg/m2
- In good health other than chronic HCV infection in the judgment of the principal investigators
- Negative for hepatitis B and HIV infection
Exclusion Criteria:
- Pregnant or breastfeeding women
- For treatment-naïve patients: any previous treatment for HCV infection
- For treatment-experienced patients: previous treatment with an experimental therapy for HCV infection
- Co-infection with HIV or hepatitis C virus (HBV)
- History or evidence of decompensated liver disease
- History or evidence of hepatocellular carcinoma
- History of alcohol abuse and/or other drug addiction </= 1 year prior to enrollment in the study
- Poorly controlled diabetes mellitus
- One or more additional known primary causes of liver disease other than hepatitis C
- History of acute or chronic pancreatitis
- Participation in an other clinical study of a new chemical entity within 30 days prior to study randomization
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
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Active Comparator
Pplacebo in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin)
|
180 mcg sc weekly
1000 mg or 1200 mg orally daily
Orally b.i.d.
|
Experimental: Setrobuvir
Setrobuvir (800 mg orally b.i.d loading dose followed by 200 mg orally .b.i.d.) in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin)
|
180 mcg sc weekly
1000 mg or 1200 mg orally daily
Loading dose of 800 mg orally b.i.d on Day 1, followed by 200 mg orally b.i.d., 28 or 48 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients achieving sustained virologic response (SVR24), defined as undetectable hepatitis C virus (HCV) RNA at 24 weeks after discontinuation of all study drugs
Time Frame: 24 weeks after discontinuation of all study drugs (treatment duration 28 or 48 weeks)
|
24 weeks after discontinuation of all study drugs (treatment duration 28 or 48 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients achieving undetectable HCV RNA (defined as HCV RNA < 15 IU/mL) at each visit through Week 24
Time Frame: 24 weeks
|
24 weeks
|
Proportion of treatment-naïve patients eligible to stop all treatment at Week 28
Time Frame: 28 weeks
|
28 weeks
|
Safety: Incidence of adverse events
Time Frame: up to approximately 72 weeks
|
up to approximately 72 weeks
|
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
January 1, 2011
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
July 17, 2013
First Submitted That Met QC Criteria
July 17, 2013
First Posted (Estimate)
July 19, 2013
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
- Antimetabolites
- Ribavirin
- Peginterferon alfa-2a
Other Study ID Numbers
- NP28302
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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