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

Phase 2Active Not RecruitingNCT07245953

Suzhou HepaThera Biotech Co., Ltd.60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Hepatitis B

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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;

Locations (12)

Beijing Ditan Hospital Capital Medical University

Beijing, Beijing Municipality, China

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China

Guangzhou Eighth People's Hospital, Guangzhou Medical University

Guangzhou, Guangdong, China

Nanfang Hospital

Guangzhou, Guangdong, China

Qingyuan People's Hospital

Qingyuan, Guangdong, China

Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine

Nanning, Guangxi, China

Henan Infectious Diseases Hospital , The Sixth People's Hospital of Zhengzhou

Zhengzhou, Henan, China

The Second Hospital of Nanjing

Nanjing, Jiangsu, China

Zhenjiang Third People's Hospital (Zhenjiang Infectious Diseases Hospital)

Zhenjiang, Jiangsu, China

Nanchang Ninth Hospital

Nanchang, Jiangxi, China

...and 2 more locations

Outcomes

Primary Outcomes

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

Time frame: From enrollment to the end of treatment at up to 60 weeks

Secondary Outcomes

Proportion of participants achieving HBV DNA lower than LLOQ after stopping all anti-HBV treatment

Time frame: From enrollment to the end of treatment at up to 60 weeks

HBsAg loss rate at W24, W36, W60

Time frame: From enrollment to the end of treatment at up to 60 weeks

Maximum Change of Serum HBsAg From Baseline Description

Maximum change of serum HBsAg from Day 1 until 36 weeks post last dose (negative values mean reductions from baseline, positive values mean increased from baseline)

Time frame: Up to 36 weeks

Maximum Change of Serum HBV DNA From Baseline Description

Maximum change of serum HBV DNA from Day 1 until 36 weeks (negative values mean reductions from baseline, positive values mean increased from baseline)

Time frame: Up to 36 weeks.

Incidence of adverse events (AEs) and serious adverse events (SAEs)

Number of subjects with adverse events (AEs) and serious adverse events (SAEs) assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Time frame: From enrollment to the end of treatment at up to 60 weeks

Clinically significant abnormalities

Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0

Time frame: From enrollment to the end of treatment at up to 60 weeks

Maximum Plasma Concentration (Cmax)

Cmax of HT-101 and its metabolite in plasma. First administration: Predose 1 hour; Postdose 2 hours, 4 hours, 6 hours, 8 hours. Changes in the concentration of HT-102 in serum, From Day1 until 36 weeks.

Time frame: HT-101: From predose 1 hour to postdose 8 hours. HT-102: UP to 36 weeks.

Time to Reach Maximum Plasma Concentration (Tmax)

Tmax of HT-101 and its metabolite in plasma. First administration: Predose 1 hour; Postdose 2 hours, 4 hours, 6 hours, 8 hours. Changes in the concentration of HT-102 in serum, From Day1 until 36 weeks.

Time frame: HT-101: From predose 1 hour to postdose 8 hours. HT-102: UP to 36 weeks.

Area Under the Plasma Concentration Versus Time Curve (AUC)

AUC of HT-101 and its metabolite from time 0 to last measurable time. First administration: Predose 1 hour; Postdose 2 hours, 4 hours, 6 hours, 8 hours. Changes in the concentration of HT-102 in serum, From Day1 until 36 weeks.

Time frame: HT-101: From predose 1 hour to postdose 8 hours. HT-102: UP to 36 weeks.

Titers of Anti-drug Antibody (ADA) to HT-102 or HT-101

ADA analysis for predose 36weeks

Time frame: UP to 36 weeks