Study Comparing BMS-790052 (Daclatasvir) to Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Untreated Hepatitis C Patients
Status: | Completed |
---|---|
Conditions: | Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 11/18/2012 |
Start Date: | February 2012 |
End Date: | June 2014 |
Contact: | For participation information at a USA site use a phone number below. For site information outside the USA please email: |
Email: | Clinical.Trials@bms.com |
A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared With Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C
The purpose of this study is to compare the effectiveness of BMS-790052 (Daclatasvir) and
Telaprevir when given in combination with Peginterferon alfa-2a and Ribavirin in genotype 1b
patients
Allocation: Randomized Stratified
Inclusion Criteria:
- Subjects chronically infected with HCV genotype 1a or 1b
- HCV RNA viral load ≥ 10,000 IU/mL
- No prior treatment including but not limited to interferon, ribavirin and
direct-acting antivirals
- if no prior history of cirrhosis liver biopsy within 3 years or Fibroscan® within 1
year
- Body Mass Index (BMI) of 18 to 35 kg/m2
- Negative for Human immunodeficiency virus (HIV) and Hepatitis B
Exclusion Criteria:
- Evidence of decompensated liver disease
- Evidence of medical condition contributing to chronic liver disease other than HCV
We found this trial at
23
sites
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
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Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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Albert Einstein Medical Center Einstein Healthcare Network is a private, not-for-profit organization with several major...
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