A Study to Assess the Efficacy and Safety of Burfiralimab(hzVSF-v13) and OAD (Oral Antiviral Drug) - Trial NCT05808335
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.
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Study Focus
Sponsor & Location
ImmuneMed, Inc.
Timeline & Enrollment
Phase 2
Jan 11, 2022
Dec 04, 2024
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
Data Source
ClinicalTrials.gov
NCT05808335
Non-Device Trial