A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Switching from Tenofovir Disoproxil Fumarate (TDF) 300 mg QD to Tenofovir Alafenamide (TAF) 25mg QD in Subjects with Chronic Hepatitis B who are Virologically Suppressed

ID Number 17-1092

Principal Investigator(s)
Ritu Agarwal

Department(s) or Division(s)
Liver Diseases

Description

This is A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Switching from Tenofovir Disoproxil Fumarate (TDF) 300 mg QD to Tenofovir Alafenamide (TAF) 25mg QD in Subjects with Chronic Hepatitis B who are Virologically Suppressed.

The purpose of this study is to evaluate the safety and effectiveness of switching from Tenofovir Disoproxil Fumarate (TDF) to Tenofovir Alafenamide (TAF) in subjects with CHB. The active part of TAF that works against the HBV virus is the same as the active part of TDF. TAF (Vemlidy®) is currently approved for the treatment of CHB in the US by FDA. TDF is currently approved for the treatment of HBV infection.

This study is a randomized and double-blind study. Double-blind means subjects and the study doctor will not know what study drug they will be taking. The study doctor can find out which study drug subjects will be taking if medically needed. The study will be double blinded for the first 48 weeks (roughly 1 year). After completing the blinded treatment, subjects will be switched to open label (both subjects and the study doctor will know what study drug they are taking) study treatment for another 48 weeks (until week 96).

All of the study drug will be supplied Gilead Sciences, Inc., which is also the sponsor of this study. All pills must be taken once a day, at the same time everyday, with or without food. If subjects have been taking TDF 300 mg with food previously, subjects should continue to take study drug with food; or if you have been taking TDF 300 mg without food subjects should continue to take their study drug every day as instructed by the study doctor.

Taking part in this study will last about 96 weeks (roughly 2 years), not including the screening visit and follow up period (if needed). During this time, subjects will be required to visit the clinic at least 11 times.



Contact Information
Meredith Lewis
(212) 241-8903
meredith.lewis@mssm.edu

Recruiting Patients: No