The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF)-containing regimens at Week 24 in participants with chronic hepatitis B virus (HBV) infection and Stage 2 or greater chronic kidney disease who have received a liver transplant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Tablet administered orally
Tablet administered orally
Other approved antivirals (such as lamivudine, entecavir, or immunoglobulin antihepatitis B) administered per local practice
Auckland City Hospital
Auckland, New Zealand
Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR) at Week 24 Using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation
Time frame: Baseline, Week 24
Percentage of Participants With HBV DNA < 20 IU/mL at Week 24
Time frame: Week 24
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 24
Time frame: Baseline, Week 24
Percent Change From Baseline in Hip BMD at Week 48
Time frame: Baseline, Week 48
Percent Change From Baseline in Spine BMD at Week 24
Time frame: Baseline, Week 24
Percent Change From Baseline in Spine BMD at Week 48
Time frame: Baseline, Week 48
Change From Baseline in Serum Creatinine at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Serum Creatinine at Week 48
Time frame: Baseline, Week 48
Change From Baseline in Serum eGFR_CKD-EPI at Week 48
Time frame: Baseline, Week 48
Percentage of Participants With HBV DNA < 20 IU/mL at Week 48
Time frame: Week 48
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