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

Suzhou HepaThera Biotech Co., Ltd.

Status and phase: Active, not recruiting; Phase 2

Conditions: Chronic Hepatitis B

Treatments: Drug: HT-101; Drug: HT-102 placebo; Drug: HT-101 placebo; Drug: HT-102

Study type: Interventional

Funder types: Industry

Identifiers

NCT07245953

HT-101&HT-102-201

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Cohort A (HT-101 + HT-102)

Experimental group

Description:

Participants will receive HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks

Treatment:

Drug: HT-102

Drug: HT-101

Cohort B （placebo；HT-101+HT-102）

Experimental group

Description:

Participants will receive Placebo injection, administered Q4W for 8 weeks and sequential dosed with HT-101 injection combined with HT-102 injection, administered once every 4 weeks for another 16 weeks

Treatment:

Drug: HT-102

Drug: HT-101 placebo

Drug: HT-102 placebo

Drug: HT-101