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TAF vs TDF in Liver Transplant Recipients with Chronic HBV and CKD
NCT02862548Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2016
- Primary completion
- Feb 2018
- Countries
- 1
- Sponsor
- Gilead Sciences
- Modality
- Small Molecules
- Conditions
- Chronic Hepatitis B (CHB)
01
Overview
Phase 2, randomised, open-label trial of tenofovir alafenamide in Chronic Hepatitis B (CHB) (3 arms), sponsored by Gilead Sciences. Primary endpoints: Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR) Using CKD-EPI Creatinine Equation at 24 weeks and Percentage of Participants With HBV DNA < 20 IU/mL at 24 weeks. Started Sep 2016; status: completed.
02
Design
3 arms- Study design
- RandomizedOpen-label
TAF Arm
Tenofovir alafenamide 25 mg once daily
TDF Arm
Tenofovir disoproxil fumarate containing regimens
Extension Arm
Open-label TAF 25 mg once daily for all participants
03
Who it enrols
Adult liver transplant recipients with chronic HBV infection and Stage 2 or greater CKD (eGFR < 90), currently maintained on TDF-containing regimen with viral suppression.
04
Endpoints
Primary
Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR) Using CKD-EPI Creatinine Equation
Percentage of Participants With HBV DNA < 20 IU/mL
Secondary
Percent Change From Baseline in Hip Bone Mineral Density (BMD)
Percent Change From Baseline in Spine Bone Mineral Density (BMD)
Change From Baseline in Serum Creatinine
Change From Baseline in Serum eGFR_CKD-EPI
Percentage of Participants With HBV DNA < 20 IU/mL
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