A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacyof Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected with Chronic HCV for Use in the Peri-Operative Liver Transplantation Setting
A study for liver transplant patients with Chronic HCV using study drug Harvoni
Sponsor: Gilead Sciences
Enrolling: Male and Female Patients
Clinic Visits: 26
IRB Number: AAAO4208
U.S. Govt. ID: NCT02350569
Contact: Eric Przybyszewski: 212-305-3839 / emp2165@cumc.columbia.edu
Additional Study Information: The purpose of this study is to see if the study drug Harvoni given for 4 weeks immediately after liver transplantation is safe and able to clear the Hepatitis C virus (HCV) from the body. This study will test a drug named Harvoni for the treatment of chronic genotype 1 or 4 Hepatitis C Virus (HCV) in peri-operative liver transplant patients. Harvoni (LDV/SOF FDC) is approved in the United States for treatment of chronic genotype 1 HCV infection.in adult patients but not for genotype 4. It is still being tested in research studies for genotype 4.
This study is closed
Investigator
Elizabeth Verna, MD
Do You Qualify?
Do you currently suffer from chronic HCV infection? Yes No
Are you currently on the liver transplantation wait list? Yes No
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For more information, please contact:
Eric Przybyszewski
emp2165@cumc.columbia.edu
212-305-3839
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