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NCT05808335Recruiting

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

A Phase IIa Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Oral Antiviral Agents/hzVSF-v13 Combination Therapy vs Oral Antiviral Monotherapy in Chronic Hepatitis B Patients
ImmuneMed, Inc.Phase 2ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Chronic Hepatitis B
Drug/Device/Intervention
Standard of care
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
ImmuneMed, Inc.
Location
Seoul,Seoul,Seoul,Seoul, South Korea
Timeline & enrollment
Phase
Phase 2
Start date
Jan 11, 2022
End date
Dec 04, 2024
Enrollment
32 participants
Primary outcome

Change in HBsAg from the baseline at 24 weeks (log10 IU/mL)

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.

ICD-10 classifications
Acute hepatitis BChronic viral hepatitis B without delta-agentAcute delta-(super)infection in chronic hepatitis BChronic viral hepatitis B without delta-agent : other and unspecified phaseChronic viral hepatitis B without delta-agent : immune-tolerant phase
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05808335
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05808335 through Pure Global AI's free database. This Phase 2 trial is sponsored by ImmuneMed, Inc. and is currently Recruiting. The study focuses on Chronic Hepatitis B. Target enrollment is 32 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.