NCT07245953Active, not recruitingPhase 2
A Clinical Study of HT-101 and HT-102 in Patients With Chronic Hepatitis B Virus Infection
A Clinical Study to Evaluate the Efficacy and Safety of HT-101 Injection Combined With HT-102 Injection in Patients With Chronic Hepatitis B
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 17 Nov 2025
- Start date
- 5 Nov 2025
- Primary completion date
- Feb 2027
- Lead sponsor
- Suzhou HepaThera Biotech Co., Ltd.
- Diseases
- Hepatitis B
- NCT number
- NCT07245953
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 5 Nov 2025 to the primary completion date, Feb 2027
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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;
Who the study is looking for
- 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;
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Ditan Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Sichuan Provincial People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Mengchao Hepatobiliary Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Nanfang Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Guangzhou Eighth People's Hospital, Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Nanchang Ninth Hospital Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| The Second Hospital of Nanjing Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
| Qingyuan People's Hospital Coordinator of this site? Confirm its status | Qingyuan | China | Unknown status |
| Shanghai Public Health Clinical Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Henan Infectious Diseases Hospital , The Sixth People's Hospital of Zhengzhou Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Zhenjiang Third People's Hospital (Zhenjiang Infectious Diseases Hospital) Coordinator of this site? Confirm its status | Zhenjiang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.