Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Clinical Study to Evaluate the Efficacy of TQA3038 Injection in Patients With Chronic Hepatitis B
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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
Conditions
Interventions
TQA3038 injection/placebo
TQA3038 is a Anti-Hepatitis B virus (HBV) drugs.
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