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A Clinical Study of HT-101 and HT-102 in Patients With Chronic Hepatitis B Virus Infection
Sponsor: Suzhou HepaThera Biotech Co., Ltd.
Summary
This study is A multicenter, randomized, double-blind, placebo-controlled phase 2 clinical study to evaluate the efficacy and safety of HT-101 injection combined with HT-102 injection in patients with chronic hepatitis B. It consists of two phases: the main trial and the extension period. The main trial phase aims to explore the efficacy of different courses of HT-101 injection combined with HT-102 injection in treating patients with chronic hepatitis B and evaluate the optimal treatment strategy. The extension period phase, based on the main trial, assesses the long-term safety and efficacy of HT-101 injection combined with HT-102 injection.
Official title: A Clinical Study to Evaluate the Efficacy and Safety of HT-101 Injection Combined With HT-102 Injection in Patients With Chronic Hepatitis B
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-11-05
Completion Date
2027-05
Last Updated
2025-11-24
Healthy Volunteers
No
Conditions
Interventions
HT-101
HT-101 given by subcutaneous injection
HT-102
HT-102 given by subcutaneous injection
HT-101 placebo
HT-101 placebo given by subcutaneous injection
HT-102 placebo
HT-102 placebo given by subcutaneous injection
Locations (12)
Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
Guangzhou Eighth People's Hospital, Guangzhou Medical University
Guangzhou, Guangdong, China
Nanfang Hospital
Guangzhou, Guangdong, China
Qingyuan People's Hospital
Qingyuan, Guangdong, China
Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine
Nanning, Guangxi, China
Henan Infectious Diseases Hospital , The Sixth People's Hospital of Zhengzhou
Zhengzhou, Henan, China
The Second Hospital of Nanjing
Nanjing, Jiangsu, China
Zhenjiang Third People's Hospital (Zhenjiang Infectious Diseases Hospital)
Zhenjiang, Jiangsu, China
Nanchang Ninth Hospital
Nanchang, Jiangxi, China
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China