Trials / Unknown
UnknownNCT03519113
HBV-associated Liver Transplant(LT) Patients by IV Injecting GC1102
Dose Selection(Step 1), Non-inferiority(Step 2), Phase II/III Clinical Trials to Evaluated the Efficacy and Safety of Hepatitis B Virus-associated Liver Transplant Patients by Intravenously Injecting GC1102
- Status
- Unknown
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 186 (estimated)
- Sponsor
- Green Cross Corporation · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
This is a clinical study for GC1102 to demonstrate preventing the recurrence of hepatitis B virus (HBV) infection following liver transplantation and a dose-finding study to determine its optional dose.
Detailed description
GC1102 is a new recombinant hepatitis B immunoglobulin (HBIG) from Chinese Hamster Ovary (CHO) cells. It is a monoclonal antibody and has high affinity and avidity to hepatitis B surface antigen and several advantages compared to HBIG derived from blood plasma of human donors. Volunteers will participate in the study, receive 24-week treatment with 80,000/100,000 IU of GC1102 or I.V HBIG and be followed up till 28 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GC1102 80,000 IU | recombinant human hepatitis B immunoglobulin |
| BIOLOGICAL | GC1102 100,000 IU | recombinant human hepatitis B immunoglobulin |
| BIOLOGICAL | I.V HBIG | human anti-hepatitis B Immunoglobulin |
Timeline
- Start date
- 2018-03-29
- Primary completion
- 2022-03-31
- Completion
- 2022-09-30
- First posted
- 2018-05-08
- Last updated
- 2020-01-30
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03519113. Inclusion in this directory is not an endorsement.