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

Completed · Phase 3

Conditions studied: Hepatitis C Virus

In brief

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.

Key facts

Study ID

NCT01581203

Run by

Bristol-Myers Squibb

People needed

748

Starts

2012-05-01

Expected to finish

2014-09-01

Last updated by the study team

2015-10-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Scripps Clinic — La Jolla, California, United States
• Scpmg/ Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• University Of Colorado Denver And Hospital — Aurora, Colorado, United States
• Uf Hepatology Research At Ctrb — Gainesville, Florida, United States
• Johns Hopkins Medical Institutions — Lutherville, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Washington University School Of Medicine — St Louis, Missouri, United States
• North Shore-Long Island Jewish Health System — Manhasset, New York, United States
• Weill Cornell Medical College — New York, New York, United States
• University Of North Carolina At Chapel Hill School Of Med — Chapel Hill, North Carolina, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Baylor College Of Medicine — Houston, Texas, United States
• Vamc — Houston, Texas, United States
• Alamo Medical Research — San Antonio, Texas, United States
• Dean Clinic — Madison, Wisconsin, United States
• Local Institution — Buenos Aires, Buenos Aires, Argentina
• Local Institution — Ciudad de Buenos Aires, Buenos Aires, Argentina
• Local Institution — Prov de Santa Fe, Santa Fe Province, Argentina
• Local Institution — Darlinghurst, New South Wales, Australia
• Local Institution — Kogarah, New South Wales, Australia
• Local Institution — Randwick, New South Wales, Australia
• Local Institution — Fitzroy, Queensland, Australia
• The Health Care Authority For Baptist Health — Montgomery, Alabama, United States

Full record on ClinicalTrials.gov

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