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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06122454
Study type Interventional
Source Xi'an Xintong Pharmaceutical Research Co.,Ltd.
Contact Ding Yanhua, Master
Phone 18743062721
Email 1023307193@qq.com
Status Recruiting
Phase Phase 1/Phase 2
Start date November 10, 2022
Completion date December 30, 2024

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