Switching from TDF to TAF
Research type
Research Study
Full title
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
IRAS ID
222818
Contact name
Kosh Agarwal
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2016-003632-20
Clinicaltrials.gov Identifier
115561, IND number
Duration of Study in the UK
2 years, 7 months, 5 days
Research summary
Chronic hepatitis B (CHB) is a major public health care issue worldwide and one of the principal causes of chronic liver disease, liver scarring, and liver cancer. The hepatitis B virus (HBV) is easily transmissible. Following acute HBV infection, 5% to 10% of adults and up to 90% of children fail to produce an immune response adequate to clear the infection; these individuals become chronic carriers of the virus.
The purpose of this study is to evaluate the safety and effectiveness of switching from Tenofovir Disoproxil Fumarate (TDF) to the newer treatment Tenofovir Alafenamide (TAF) in participants with CHB. The active part of TAF which works against the Hepatitis B (HBV) virus is the same as the active part in TDF. TAF (Vemlidy®) is currently approved for the treatment of CHB in the EU by the European Commission. TDF is currently approved for the treatment of CHB in adults and in children 12 of years of age and older.
Participants have CHB and are currently taking TDF.
Participants will be one of approximately 460 participants in this study. The study will take place at approximately 50 study sites in North America, Europe, and Asia.
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, participants will be required to visit the hospital at least 11 times.
The study is double blind and randomised. ‘Double-blind’ means that the participant and the study doctor will not know what study medicine the participant will be taking for the first 48 weeks of the study.
‘Randomised’ means that the study treatment the participant will take will be chosen by chance - like flipping a coin.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
17/SC/0186
Date of REC Opinion
11 May 2017
REC opinion
Further Information Favourable Opinion