Trial intelligence / Profile preview

ANA598 in treatment-naïve genotype 1 chronic hepatitis C

NCT00978497Phase 2

Key facts

Status: Completed
Start: Sep 2009
Primary completion: Apr 2010
Countries: 2
Sponsor: Roche

Drugs: setrobuvir
Conditions: hepatitis C (HCV)

Overview

Phase 2, randomised, double-blind trial of setrobuvir in hepatitis C (HCV) (3 arms), sponsored by Roche. Primary endpoint: Undetectable HCV RNA at 12 weeks. Started Sep 2009; status: completed.

Design

3 arms

Study design: RandomizedDouble-blind

Placebo + SOC
Placebo + Peginterferon + Ribavirin
ANA598 200mg + SOC
ANA598 200mg BID + Peginterferon + Ribavirin
ANA598 400mg + SOC
ANA598 400mg BID + Peginterferon + Ribavirin

Who it enrols

Treatment-naïve patients aged 18-65 with documented chronic HCV genotype 1 infection, excluding those with HIV, HBV, or other liver diseases.

Endpoints

Primary

Undetectable HCV RNA12 weeks

Secondary

Safety and Tolerabilitythroughout study
Undetectable HCV RNA48 weeks
ANA598, Peg-IFN, and Ribavirin concentrations12 weeks
Sustained Virologic Response 24 weeks after completion24w post-therapy

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