A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir for the Treatment of Post-Liver Transplant Subjects With Chronic Hepatitis C
| Status: | No longer available |
|---|---|
| Conditions: | Hepatitis, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir for the Treatment of Subjects With Chronic Hepatitis C and Decompensated Cirrhosis or Post-Liver Transplant Subjects With Chronic Hepatitis C Recurrence
The primary objective of this program is to provide DCV for 24 weeks to be given in
combination with SOF to subjects with chronic hepatitis C with decompensated cirrhosis or
post-liver transplant subjects with chronic hepatitis C recurrence with either advanced
fibrosis or fibrosing cholestatic hepatitis and who have a serious or immediately
life-threatening condition or experienced an event that has decreased their life expectancy
to <12 months, therefore, no research hypothesis will be tested and no specific endpoints
are defined. However, safety data will be collected throughout the study as well as efficacy
data
combination with SOF to subjects with chronic hepatitis C with decompensated cirrhosis or
post-liver transplant subjects with chronic hepatitis C recurrence with either advanced
fibrosis or fibrosing cholestatic hepatitis and who have a serious or immediately
life-threatening condition or experienced an event that has decreased their life expectancy
to <12 months, therefore, no research hypothesis will be tested and no specific endpoints
are defined. However, safety data will be collected throughout the study as well as efficacy
data
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
Inclusion Criteria:
- Patients chronically infected with Hepatitis C
- Subjects who received a liver transplant, have chronic hepatitis C virus (HCV)
recurrence and advanced fibrosis (Metavir F3-F4) or fibrosing cholestatic hepatitis
- Subjects with decompensated cirrhosis defined by Child-Pugh Class C
Exclusion Criteria:
- Patients who are <18 years old
- Clinical or pathologic evidence of acute ongoing liver graft rejection
- Creatinine clearance (CrCl) ≤30 mL/min (as estimated by Cockcroft and Gault formula)
- Patients who have contraindications to either Daclatasvir (DCV) or Sofosbuvir (SOF)
- Patients who are pregnant or Women of Child Bearing Potential who are not using
required contraception
We found this trial at
20
sites
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Worchester, Massachusetts 01655
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