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A Study to Assess the Efficacy and Safety of Burfiralimab(hzVSF-v13) and OAD (Oral Antiviral Drug)

NCT05808335 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-06-15

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, parallel group, 48-week follow-up, Phase IIa clinical study. This study has been designed to evaluate the change in HBsAg (log10 IU/mL) after administration of hzVSF-v13 50 mg/dose and hzVSF-v13 200 mg/dose in combination with an oral antiviral agent (Tenofovir or entecavir, including salt-free or salt-modifying drugs) compared to an oral antiviral agent in combination with a placebo (normal saline) in patients with chronic hepatitis B who are stably receiving an oral antiviral agent (Tenofovir or entecavir, including salt-free or salt-modifying drugs) for at least 24 weeks.

Conditions

Interventions

DRUG

Standard of care

The following medications listed are allowed to be administered during the course of the clinical study. 1. Tenofovir (including salt-free or salt-modifying drugs) 2. Entecavir (including salt-free or salt-modifying drugs)

Sponsors & Collaborators

  • ImmuneMed, Inc.

    lead INDUSTRY

Principal Investigators

  • Joon Hyeok Lee, M.D. Ph.D. · Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-11
Primary Completion
2024-03-27
Completion
2024-12-04

Countries

  • South Korea

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 NCT05808335 on ClinicalTrials.gov