A Phase Ic/IIb Study to Evaluate the Efficacy，Safety and Pharmacokinetics of HST in Patients With CHB
Status:
Recruiting
Trial end date:
2024-12-30
Target enrollment:
Participant gender:
Summary
The goal of this a clinical trial is to learn about the efficacy，safety and Pharmacokinetics
of Hepenofovir Fumarate Tablets（HTS） in patients with CHB. The main questions it aims to
answer are：
1. Evaluate the efficacy and safety of multiple doses of continuous administration of HTS
in patients with chronic hepatitis B, and compare it with Tenofovir alafenamide Fumarate
tablets（TAF）.
2. To evaluate the pharmacokinetic characteristics of HTS in patients with chronic
hepatitis B after multiple oral administration.
3. To evaluate the pharmacodynamic changes of HTS in patients with chronic hepatitis B
after multiple consecutive administrations, and compare it with TAF.
Positive control drug：Tenofovir alafenamide Fumarate tablets（25mg/d） Test drug：Hepenofovir
Fumarate Tablets（10mg/d、20mg/d、40mg/qod） Test process：This study was divided into 4 groups,
with the specific list shown below. The initial plan was to include 12 subjects in each
group, stratified by HBeAg status, with 4 subjects negative for HBeAg and 8 subjects positive
for HBeAg. A total of 48 subjects were included in this trial, and they were randomly
assigned to multiple doses at a ratio of 1:1:1:1. The dosing period was 24 weeks. However,
after enrolling 37 subjects (29 positive for HBeAg and 8 negative for HBeAg), the protocol
was adjusted (V4.0): the remaining 11 subjects would be included, all of whom were over 30
years old with ALT < ULN and met all the inclusion criteria but none of the exclusion
criteria. The random assignment was: 7 subjects positive for HBeAg were randomly assigned to
HTS 10mg/day, 20mg/day, 40mg/qod and TAF 25mg/day groups at a ratio of 2:2:2:1; and 4
subjects negative for HBeAg were randomly assigned to HTS 10mg/day, 20mg/day, 40mg/qod and
TAF 25mg/day groups at a ratio of 1:1:1:1.