A Study of Setrobuvir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Genotype 1 Chronic Hepatitis C
NCT ID: NCT01903954
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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COMPLETED
PHASE2
283 participants
INTERVENTIONAL
2011-01-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active Comparator
Pplacebo in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin)
peginterferon alfa-2a [Pegasys]
180 mcg sc weekly
placebo
Orally b.i.d.
ribavirin [Copegus]
1000 mg or 1200 mg orally daily
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)
peginterferon alfa-2a [Pegasys]
180 mcg sc weekly
ribavirin [Copegus]
1000 mg or 1200 mg orally daily
setrobuvir
Loading dose of 800 mg orally b.i.d on Day 1, followed by 200 mg orally b.i.d., 28 or 48 weeks
Interventions
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peginterferon alfa-2a [Pegasys]
180 mcg sc weekly
placebo
Orally b.i.d.
ribavirin [Copegus]
1000 mg or 1200 mg orally daily
setrobuvir
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 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
Other Identifiers
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NP28302
Identifier Type: -
Identifier Source: org_study_id
NCT01281423
Identifier Type: -
Identifier Source: nct_alias