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

Conditions: HEPATITIS C VIRUS
MedDRA version: 15.0Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2011-005446-35-IT

Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1100

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 cirrhosis, OR
treatment naive;
• HCV RNA = 104 IU/mL (10,000 IU/mL);
• Seronegative for HIV and HBsAg;
• Subjects with compensated cirrhosis are permitted (compensated
cirrhotics are capped at approximately 25% of treated population).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 990
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110

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;

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of this study is to estimate efficacy, as determined by the<br>proportion of subjects with SVR12, defined as HCV RNA < LOQ at posttreatment<br>Week 12, for subjects who are prior null or partial responders<br>to P/R or who are treatment-naive.;Secondary Objective: • Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ<br>at post-treatment Week 12, for subjects who are intolerant or ineligible<br>to P/R;<br>• On treatment safety, as measured by frequency of SAEs and<br>discontinuations due to AEs through the end of treatment plus 7 days;;Primary end point(s): Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at<br>post-treatment Week 12, for all subjects who are prior null or partial<br>responders to P/R or are treatment-naive;Timepoint(s) of evaluation of this end point: At 12 weeks post-treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ<br>at post-treatment Week 12, for subjects who are intolerant or ineligible<br>to P/R;<br>• On treatment safety, as measured by frequency of SAEs and<br>discontinuations due to AEs through the end of treatment plus 7 days;;Timepoint(s) of evaluation of this end point: • Post-treatment Week 12;<br>• Through the end of treatment (maximum of 48 weeks) plus 7 days;