A Phase 2, Randomized, Open Label Study to Evaluate the Efficacy and Safety of Tenofovir Alafenamide (TAF) versus Tenofovir Disoproxil Fumarate (TDF)–containing Regimens inSubjects with Chronic HBV Infection and Stage 2 or Greater Chronic Kidney Disease Who Have Received a Liver Transplant

Gilead Sciences, Inc.0 sites50 target enrollmentJuly 7, 2016

Overview

No summary available.

Registry

who.int

Start Date

July 7, 2016

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\) Must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures
•2\) Adult male or non\-pregnant female subjects, over 18 years of age based on the date of the screening visit
•3\) Documented evidence of chronic HBV infection prior to transplantation
•4\) Primary or secondary (re\-transplant), liver alone or liver and kidney transplant recipient from deceased or living donor
•5\) Liver Transplant \=\>12 weeks prior to screening
•6\) Maintained on TDF alone or in combination with other approved antivirals for HBV
•prophylaxis or treatment
•7\) Have been on approved HBV OAV treatment for at least 12 weeks post\-transplant prior to screening, with HBV DNA \< LLOQ at screening
•8\) Screening renal function \< 90 ml/min/1\.73m^2
•9\) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

•1\) Multi\-organ transplant that includes heart or lung recipient (subjects who have their liver transplant as part of a liver\-kidney dual transplant are eligible to enroll)
•2\) Subjects with history of de novo or recurrent hepatocellular carcinoma (HCC) post\-transplant and at screening
•3\) Histological evidence of unresolved transplant rejection
•4\) Current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, or other signs of decompensated cirrhosis
•5\) Subjects meeting any of the following laboratory parameters at screening:
•a) ALT \> 10× the upper limit of normal (ULN)
•b) INR \> 1\.5 × ULN unless the subject is stable on anticoagulant regimen affecting INR
•c) Albumin \< 3\.0 g/dL
•d) Direct bilirubin \=\> 4 × ULN
•e) Platelet count \< 50,000/mL