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Daclatasvir + Asunaprevir in Japanese HCV Genotype 1b Patients

NCT01497834Phase 3

Key facts

Status: Completed
Start: Jan 2012
Primary completion: Apr 2013
Countries: 1
Sponsor: Bristol Myers Squibb
Modality: Small Molecules

Drugs: daclatasvirasunaprevir
Conditions: hepatitis C (HCV)

Overview

Phase 3, open-label, single-arm trial of daclatasvir and asunaprevir in hepatitis C (HCV), sponsored by Bristol Myers Squibb. Primary endpoint: Sustained Virologic Response at 24 Weeks Post-Treatment. Started Jan 2012; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Daclatasvir + Asunaprevir
Daclatasvir 60mg once daily and Asunaprevir 100mg twice daily for 24 weeks

Who it enrols

Japanese patients aged 20-75 with chronic HCV genotype 1b infection and high viral load (>= 100,000 IU/mL). Must be non-responders to prior interferon/ribavirin therapy or ineligible/intolerant to such therapy. Excludes patients with hepatocellular carcinoma, HBV, or HIV coinfection.

Endpoints

Primary

Sustained Virologic Response at 24 Weeks Post-Treatment24 weeks post-treatment

Secondary

HCV RNA below Lower Limit of QuantitationPost-treatment Week 24
Safety and TolerabilityEnd of treatment plus 7 days
SVR24 by IL28B GenotypeFollow-up Week 24

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