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ACTIVE NOT RECRUITING
NCT06150014
PHASE1/PHASE2

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.

View on ClinicalTrials.gov

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

Interventions

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.

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