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

NCT07245953 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-11-24

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

HT-101

HT-101 given by subcutaneous injection

DRUG

HT-102

HT-102 given by subcutaneous injection

DRUG

HT-101 placebo

HT-101 placebo given by subcutaneous injection

DRUG

HT-102 placebo

HT-102 placebo given by subcutaneous injection

Sponsors & Collaborators

  • Suzhou HepaThera Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jinlin Hou · Nanfang Hospital, Southern Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-05
Primary Completion
2027-02-28
Completion
2027-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07245953 on ClinicalTrials.gov