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NOT YET RECRUITING
NCT06452693
PHASE1/PHASE2

A Clinical Study to Evaluate the Efficacy of TQA3038 Injection in Patients With Chronic Hepatitis B

Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is divided into two parts. Phase Ib is a randomized, double-blind, placebo-controlled trial, designed to evaluate the safety, tolerability, pharmacokinetic characteristics, preliminary efficacy, and immunogenicity of TQA3038 injection in patients with chronic hepatitis B. It is expected to include 72 subjects. Phase IIa adopted an open-label, randomized, parallel-controlled design, with a total of 90 subjects included, mainly evaluating the changes in serum HBsAg compared to baseline at the end of the 48th week.

Official title: A Phase Ib/IIa Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic, and Antiviral Efficacy of TQA3038 Injection in Patients With Chronic Hepatitis B

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

162

Start Date

2024-06

Completion Date

2026-09

Last Updated

2024-06-11

Healthy Volunteers

No

Interventions

DRUG

TQA3038 injection/placebo

TQA3038 is a Anti-Hepatitis B virus (HBV) drugs.

DRUG

Nucleotide drugs Control group

Nucleotide drugs are nucleoside reverse transcriptase inhibitors.

Locations (22)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China

Gansu province people hospital

Lanzhou, Gansu, China

The Third Affiliated Hospital of Sun Yat sen University

Guangzhou, Guangdong, China

The First Affiliated Hospital of GUANGXI Medical University

Nanning, Guangxi, China

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Shiyan City Taihe Hospital

Shiyan, Hubei, China

Tongji Hospital of Tongji medical college of HUST

Wuhan, Hubei, China

Xiangya Third Hospital of Central of Central Suoth University

Changsha, Hunan, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The first hospital of Jilin University

Changchun, Jilin, China

Hepatobiliary Hospital of Jilin

Changchun, Jilin, China

The sixth people's hospital at of Shenyang

Shenyang, Liaoning, China

Shengjing Hospital Affiliated to China Medical University

Shenyang, Liaoning, China

Shandong Public Health Clinical Center

Jinan, Shandong, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

The Southwest Hospital of AMU

Chongqing, China

The Second Affilated Hospital of Chongqing medical university

Chongqing, China

Shanghai Tongren Hospital

Shanghai, China

People's Hospital of Tianjin (City)

Tianjin, China