Assessing Burfiralimab and Oral Antiviral Drug for Chronic Hepatitis B
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
This study is testing if a new treatment combining Burfiralimab with an oral antiviral can help people with chronic hepatitis B who have been on stable medication for at least 24 weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 19 Years to 64 Years |
| Sex | All |
| Sponsor | ImmuneMed, Inc. Industry-sponsored |
| Locations | 4 sites (Seoul and 3 other locations) |
| Trial ID | NCT05808335 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, double-blind, parallel group clinical study aims to evaluate the efficacy and safety of Burfiralimab (hzVSF-v13) in combination with an oral antiviral agent in patients with chronic hepatitis B. Participants who have been on stable antiviral treatment for at least 24 weeks will be randomized into three groups: one receiving Burfiralimab 50 mg, another receiving Burfiralimab 200 mg, and a control group receiving a placebo. The study will follow participants for 48 weeks, measuring changes in HBsAg levels to assess treatment effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with chronic hepatitis B who have been on stable antiviral therapy for at least 24 weeks.
Not a fit: Patients with significant liver disease from causes other than chronic HBV infection or those with uncontrolled diabetes or hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients with chronic hepatitis B.
How similar studies have performed: While similar studies have explored antiviral combinations, the specific approach of using Burfiralimab in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Those who have a history of a diagnosis of chronic hepatitis B more than 24 weeks prior to screening and have been maintaining HBsAg positive at screening 2. Those who have an HBV DNA level that is below \<20 IU/mL 3. Those who have been receiving tenofovir (including Tenofovir's salt-free or salt-modifying drugs), or entecarvir (including Entecavir's salt-free or salt-modifying drugs) stably for ≥24 weeks prior to screening and anticipated to maintain the identical drug with equivalent dosage and administration during the clinical trial. Exclusion Criteria: 1. Those with a history of clinically significant chronic liver disease caused by other than chronic HBV infection at the time of screening 2. Patients with a signs of loss of liver function and decompensation of liver disease 3. Patients with uncontrolled diabetes (HbA1c \>7.5%) 4. Patients with uncontrolled hypertension
Where this trial is running
Seoul and 3 other locations
- Chung-Ang University Hospital — Seoul, Korea, Republic of (Recruiting)
- Samsung Medical Center — Seoul, Korea, Republic of (Recruiting)
- Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)
- Severance Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Joon Hyeok Lee, M.D. Ph.D. — Samsung Medical Center
- Study coordinator: Sungman Park, Ph.D.
- Email: smpark@immunemed.co.kr
- Phone: 82-33-258-6563
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.