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.
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
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
19
sites
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Scripps Clinic Scripps Clinic in Torrey Pines has been providing exceptional medical care to people...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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