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NCT07245953
PHASE2

A Clinical Study of HT-101 and HT-102 in Patients With Chronic Hepatitis B Virus Infection

Sponsor: Suzhou HepaThera Biotech Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

HT-101

HT-101 given by subcutaneous injection

DRUG

HT-102

HT-102 given by subcutaneous injection

DRUG

HT-101 placebo

HT-101 placebo given by subcutaneous injection

DRUG

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