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

Status:	Completed
Conditions:	Hepatitis
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	May 2012
End Date:	September 2014

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

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.

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

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- Males and females, ≥ 18 years of age

- HCV Genotype 1b who previously failed treatment with peginterferon alfa and
ribavirin, classified as previous null or partial responders based on previous
therapy, OR intolerant or ineligible to P/R due to neutropenia, anemia, depression or
thrombocytopenia with fibrosis/cirrhosis, OR treatment naive

- HCV RNA ≥ 10,000 IU/mL

- Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen
(HBsAg)

- Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped
at approximately 25% of treated population)

Exclusion Criteria:

- Prior treatment of HCV with HCV direct acting antiviral (DAA)

- Evidence of a medical condition contributing to chronic liver disease other than HCV

- Evidence of decompensated liver disease including, but not limited to, a history or
presence of ascites, bleeding varices, or hepatic encephalopathy

- Diagnosed or suspected hepatocellular carcinoma or other malignancies

- Uncontrolled diabetes or hypertension

We found this trial at

sites

VAMC

Houston, Texas 77030

from

Houston, TX