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Evaluate the Efficacy and Safety of HLX10 in Chronic Hepatitis B Patients

NCT04133259 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2020-10-20

No results posted yet for this study

Summary

A multiple-center, open-label, Phase II clinical trial to evaluate the safety and the efficacy of HLX10 in chronic hepatitis B patients.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

Recombinant anti-programmed death-1 (PD-1) humanized monoclonal antibody

Treatment of CHB patient with HLX10

DRUG

Nucleoside/nucleotide analogues

Treatment NAs for chronic hepatitis B subject to achieve adequate HBV viral suppression

Sponsors & Collaborators

  • Henlix, Inc

    lead INDUSTRY

Principal Investigators

  • Jia-Horng Kao, MD, PhD · National Taiwan University Hospital

  • Cheng-Yuan Peng, MD, PhD · China Medical University Hospital

  • Chia-Yen Dai, MD, PhD · Kaohsiung Medical University Chung-Ho Memorial Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-12-31
Primary Completion
2022-04-30
Completion
2022-07-30

Countries

  • Taiwan

Study Locations

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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 NCT04133259 on ClinicalTrials.gov