NCT01581203

Phase III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Ineligibles. Naives)

A Phase 3 Study With Asunaprevir and Daclatasvir (DUAL) for Null or Partial Responders to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligible to P/R Subjects and Treatment-Naive Subjects With Chronic Hepatitis C Genotype 1b Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 748 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to estimate efficacy, as determined by the proportion of subjects with Sustained virologic response at post-treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) \< Limit of quantitation (LOQ) at post-treatment Week 12, for subjects who are prior null or partial responders to P/R or who are treatment-naive.

Detailed description

Allocation: Treatment naive cohort: Randomized Controlled Trial, Null/partial responder and intolerant/ineligible cohorts: N/A (Single arm study) Masking: Treatment naive cohort: Double Blind, Null/partial responder and intolerant/ineligible cohorts: Open Intervention Model: Treatment naive cohort: Parallel, Null/partial responder and intolerant/ineligible cohorts: Single group

Conditions

• Hepatitis C Virus

Interventions

Type	Name	Description
DRUG	Asunaprevir (ASV)
DRUG	Daclatasvir (DCV)
DRUG	Pegylated-interferon alfa 2a (PegIFN)
DRUG	Ribavirin (RBV)

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-10-01
• Completion: 2014-09-01
• First posted: 2012-04-20
• Last updated: 2015-10-09

Locations

116 sites across 18 countries: United States, Argentina, Australia, Austria, Canada, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Russia, South Korea, Spain, Taiwan, United Kingdom