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

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:
  • ANA598

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.

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

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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