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Clinical Trials in China / NCT07245953
Active, not recruiting Phase 2

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

NCT07245953 · tracked via the Priya Life Science China tracker
Sponsor
Suzhou HepaThera Biotech Co., Ltd.
Phase
Phase 2
Started
2025-11-05
Last updated
2025-11-24

Condition(s) studied

Chronic Hepatitis B

Investigational drug(s) / intervention(s)

HT-101HT-102HT-101 placeboHT-102 placebo

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * Subjects were eligible for inclusion into the study if they met each of the following criteria: Patient with CHB Male subjects weighed ≥ 45.0 kg, female subjects weighed ≥ 40.0 kg, with a body mass index (BMI) between 19.0 and 30.0 kg/m\^2 (inclusive); Chronic HBV infection for \>/= 6 months; The quantitation level of HBsAg was \> 100 IU/mL and \<3000 IU/mL; The quantitation level of HBV DNA \<LLOQ; · On Nas therapy for \>/= 6 months at the time of screening Subjects promised to use effective contraception for at least 1 month before screening, and have no fertility, donate sperm or eggs and voluntarily take highly effective physical contraception (including partners) during the trial and within 3 months after the end of the trial; Exclusion Criteria: * Subjects were excluded from the study if one or more of the following criteria were applicable Participants with history of drug allergy or specific allergy; Participants who had psychiatric conditions or diseases in cardiovascular, respiratory, endocrine, kidney, liver, digestive tract, skin, immune, blood, nerve and other systems; Participants with history of active pathological bleeding, or bleeding tendency; Participants with abnormal results of physical examination, vital sign examination, ECG examination, laboratory test in the screening period which were judged as clinically significant by clinicians; Participants with significant liver fibrosis or cirrhosis; Participants with symptoms or a history of hepatic decompensation; Participants with a history or suspected risk of liver cancer;

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
Beijing Ditan Hospital Capital Medical University Beijing Beijing Municipality
Mengchao Hepatobiliary Hospital of Fujian Medical University Fuzhou Fujian
Guangzhou Eighth People's Hospital, Guangzhou Medical University Guangzhou Guangdong
Nanfang Hospital Guangzhou Guangdong
Qingyuan People's Hospital Qingyuan Guangdong
Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine Nanning Guangxi
Henan Infectious Diseases Hospital , The Sixth People's Hospital of Zhengzhou Zhengzhou Henan
The Second Hospital of Nanjing Nanjing Jiangsu
Zhenjiang Third People's Hospital (Zhenjiang Infectious Diseases Hospital) Zhenjiang Jiangsu
Nanchang Ninth Hospital Nanchang Jiangxi
Shanghai Public Health Clinical Center Shanghai Shanghai Municipality
Sichuan Provincial People's Hospital Chengdu Sichuan

More Suzhou HepaThera Biotech Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07245953 on ClinicalTrials.gov ↗ ← All trials in China