Status:
ACTIVE_NOT_RECRUITING
A Clinical Study of HT-101 and/or HT-102 in Patients With Chronic Hepatitis B Virus Infection
Lead Sponsor:
Suzhou HepaThera Biotech Co., Ltd.
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
This study is A multicenter, open-label, partial multiple-ascending doses phase1b/2 in which participants with chronic hepatitis B virus (HBV) infection will receive HT-101 and/or HT-102 and be assess...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
December 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2027
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT07183306
Start Date
December 30 2024
End Date
May 3 2027
Last Update
September 19 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100015
2
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian, China, 361001
3
Guangzhou Eighth People's Hospital, Guangzhou Medical University
Guangzhou, Guangdong, China, 510440
4
Nanfang Hospital
Guangzhou, Guangdong, China, 510515