At a glance
ClinicalIndex Comparison Record- ✓Documented evidence of chronic HBV infection
- ✓HBeAg-negative and HBeAb-positive at screening
- ✓Screening HBV DNA ≥2×10⁴ IU/mL
- ✓Screening ALT >60 U/L (males) or >38 U/L (females) and ≤10× upper limit of normal
- ✕Co-infection with hepatitis C, HIV, or hepatitis D virus
- ✕Evidence of hepatocellular carcinoma
- ✕Any history of or current evidence of clinical hepatic decompensation
- ✕AST >10× upper limit of normal
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Tenofovir Alafenamide (TAF) 25 mg QD Versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg-Negative, Chronic Hepatitis B
In Brief
A Phase 3 clinical trial evaluating TAF, TDF, and 2 other interventions for HBV and Chronic HBV Infection. Completed, enrolled 155 participants across 29 sites.
Detailed Summary
The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B virus (HBV) infection in China.
Study Details
Timeline
Interventions
TAF 25 mg tablet administered orally once daily
TDF 300 mg tablet administered orally once daily
TAF placebo tablet administered orally once daily
TDF placebo tablet administered orally once daily