HT-101 and HT-102 Injections for Chronic Hepatitis B
HT-101
+ HT-102
Blood-Borne Infections+14
+ Chronic Disease
+ Communicable Diseases
Treatment Study
Summary
Study start date: December 30, 2024
Actual date on which the first participant was enrolled.This clinical study aims to explore the safety and effects of two new injections, HT-101 and HT-102, in patients who have chronic hepatitis B virus infection. Chronic hepatitis B is a long-lasting liver infection caused by the hepatitis B virus, and it can lead to serious liver problems. The study seeks to understand how the body handles these new medications and how they affect the virus. By researching these injections, there is hope to find more effective treatments for managing chronic hepatitis B, improving the quality of life for those affected. Participants in the study will receive injections of HT-101 and/or HT-102 every four weeks, over a period of at least 24 weeks. Some groups will receive just HT-101, others just HT-102, and some will receive a combination of both. Throughout the study, all participants will also continue their existing treatment with nucleoside analogues, a common therapy for hepatitis B. The study will closely monitor the participants to evaluate the safety and side effects of the injections, as well as how well the medications work in managing the infection.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.86 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Subjects were eligible for inclusion into the study if they met each of the following criteria: Patient with CHB Male subjects weighed ≥ 50.0 kg, female subjects weighed ≥ 45.0 kg, with a body mass index (BMI) between 19.0 and 28.0 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;
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.6 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalGroup 5
ExperimentalGroup 6
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 7 locations
Beijing Ditan Hospital Capital Medical University
Beijing, ChinaOpen Beijing Ditan Hospital Capital Medical University in Google MapsXiamen Hospital of Traditional Chinese Medicine
Xiamen, ChinaGuangzhou Eighth People's Hospital, Guangzhou Medical University
Guangzhou, ChinaNanfang Hospital
Guangzhou, China