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)
Proportion of participants achieving HBsAg < lower limit of detection (LOD) 0.05 International Unit/mL (IU/mL) and HBV DNA < lower limit of quantitation (LLOQ) with or without anti-HBs seroconversion at W60 — From enrollment to the end of treatment at up to 60 weeks
Trial sites (12)
Facility
City
Region
Status
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
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.
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