BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis C
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2011 |
| End Date: | January 2014 |
Open-Label, Single Arm Evaluation of BMS-790052 (Daclatasvir) in Combination With Peg-Interferon Alfa-2a and Ribavirin in Black-African Americans, Latinos and White-Caucasians With Chronic Hepatitis C Genotype 1 Infection
The purpose of this study is to compare the rates of sustained virologic response in each
cohort (Black-African Americans, Latinos) in this study to historical rate.
cohort (Black-African Americans, Latinos) in this study to historical rate.
Inclusion Criteria:
- Participants chronically infected with Hepatitis C virus (HCV) genotype 1
- HCV RNA viral load of ≥10,000 IU/mL at screening
- No previous exposure to interferon formulation, ribavirin or HCV direct antiviral
agent
- Self-described as Black-African American, Latino or White-Caucasian
- Results of a liver biopsy obtained ≤36 months prior to first treatment compensated
cirrhotics with HCV liver biopsy from any time prior to first treatment.
Compensated cirrhotics were capped at approximately 25%
Exclusion Criteria:
- Evidence of decompensated liver disease
- Documented or suspected Hepatocellular carcinoma (HCC)
- Positive for Hepatitis B or HIV 1/HIV 2 antibody at screening
We found this trial at
36
sites
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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University of Miami A private research university with more than 15,000 students from around the...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
(504) 588-5912
Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
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2315 Stockton Blvd.
Sacramento, California 95817
Sacramento, California 95817
(916) 734-2011
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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