Trials / Recruiting
RecruitingNCT05686759
A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.
A Phase 3b Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj. in Post-liver Transplant Patients
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 105 (estimated)
- Sponsor
- GC Biopharma Corp · Industry
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of undiluted intravenous infusion of I.V.-Hepabig inj. in post-liver transplant patients
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Undiluted I.V.-Hepabig inj(GC5103) | undiluted I.V.-Hepabig inj(GC5103) 10,000 International Unit |
| BIOLOGICAL | Diluted I.V.-Hepabig inj(GC5103) | Diluted I.V.-Hepabig inj(GC5103) 10,000 International Unit |
Timeline
- Start date
- 2023-04-13
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
- First posted
- 2023-01-17
- Last updated
- 2025-06-25
Locations
8 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05686759. Inclusion in this directory is not an endorsement.