NCT06150014

A Clinical Study of TQA3605 Tablets Monotherapy or in Combination With Nucleoside (Acid) Analogues in Treatment Naive and Treated Patients With Chronic Hepatitis B

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Chronic Hepatitis b

Interventions

Type	Name	Description
DRUG	Placebo	TQA3605 placebo tablets were orally administered on an empty stomach (at least 2 hours before or after meals) with warm.
DRUG	TQA3605 tablets	TQA3605 inhibits viral replication.
DRUG	Entecavir dispersible tablets	Entecavir inhibits viral replication and indicated for chronic hepatitis B treatment.
DRUG	Tenofovir disoproxil fumarate tablet	Tenofovir disoproxil fumarate is a Nucleotide reverse transcriptase inhibitor.
DRUG	Tenofovir alafenamide fumarate tablet	Tenofovir alafenamide fumarate inhibits hepatitis B virus replication.

Timeline

• Start date: 2023-12-07
• Primary completion: 2025-12-01
• Completion: 2026-09-01
• First posted: 2023-11-29
• Last updated: 2024-11-14

Locations

3 sites across 1 country: China