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A Clinical Study of TQA3605 Tablets Monotherapy or in Combination With Nucleoside (Acid) Analogues in Treatment Naive and Treated Patients With Chronic Hepatitis B
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Summary
A randomized, double-blind Phase Ib/IIa multicenter trial design was used. All eligible subjects received TQA3605 tablets/placebo plus nucleoside (acid) analogues. A total of 88 subjects were required
Official title: Randomized, Double-blind, Placebo-controlled Phase Ib/IIa Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets Monotherapy or in Combination With Nucleoside (Acid) Analogues in Treatment-naïve Patients and Treated Patients With Chronic Hepatitis B
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
88
Start Date
2023-12-07
Completion Date
2026-09
Last Updated
2024-11-14
Healthy Volunteers
No
Conditions
Interventions
Placebo
TQA3605 placebo tablets were orally administered on an empty stomach (at least 2 hours before or after meals) with warm.
TQA3605 tablets
TQA3605 inhibits viral replication.
Entecavir dispersible tablets
Entecavir inhibits viral replication and indicated for chronic hepatitis B treatment.
Tenofovir disoproxil fumarate tablet
Tenofovir disoproxil fumarate is a Nucleotide reverse transcriptase inhibitor.
Tenofovir alafenamide fumarate tablet
Tenofovir alafenamide fumarate inhibits hepatitis B virus replication.
Locations (3)
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shannxi, China