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Also known as Hepatitis B Immune Globulin (Boca HBVIg), Nabi-HB, HepaGam B, HBIG
Hepatitis B Immune Globulin · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| Hepatitis B Immune Globulin (Boca HBVIg) | BIOLOGICAL | Phase I (12 weeks): Intravenous Boca HBVIg 10,000 IU administered intraoperatively during the anhepatic phase, following reperfusion, daily on days 1-7, once during week 4 and once during week 8 (total of 11 doses). Phase II (24 weeks): Starting at 12 weeks post liver transplantation, Boca HBVIg will be reduced to 5,000 IU given intravenously on a monthly basis for patients who had an anti-HBs trough titer greater than or equal to 500 IU/L at 8 weeks without the need for additional Boca HBVIg doses. Patients with an 8 week trough level less than 500 IU/L will receive 10,000 IU Boca HBVIg every 4 weeks for the remainder of the study. |
Inclusion Criteria: * Be 18 years old or greater, either male or female, of any ethnic background. * Be positive for HBsAg. Patients may be either positive or negative for anti-HDV, HBeAg, and HBV DNA (non-PCR assay). * Be diagnosed with HBV-induced liver disease including either: * HBsAg positive ...
Hepatitis B Immune Globulin is being developed for Hepatitis B Virus Associated Liver Disease. It is a monoclonal antibody studied in patients undergoing liver transplantation, where it was evaluated in combination with lamivudine. The program targets the infectious disease therapeutic area.
Hepatitis B Immune Globulin is being developed by ADMA Biologics Inc, which trades under the ticker ADMA. The company is the sponsor associated with the clinical program for this monoclonal antibody candidate in Hepatitis B Virus Associated Liver Disease.
Hepatitis B Immune Globulin is in Phase 1 development. It is an investigational product and has not been approved by the FDA. The Phase 1 program has completed, with no active trials currently listed for this candidate.
Hepatitis B Immune Globulin has been studied in one clinical trial, NCT01421212, a completed Phase 1 pilot study. That trial enrolled 30 patients in the United States and assessed the pharmacokinetics of intravenous Hepatitis B Immune Globulin used in combination with lamivudine in patients with Hepatitis B Virus Associated Liver Disease undergoing liver transplantation.
Yes, Hepatitis B Immune Globulin is also known as Hepatitis B Immune Globulin (Boca HBVIg). Boca HBVIg refers to the same ADMA Biologics monoclonal antibody candidate being studied in Hepatitis B Virus Associated Liver Disease, so searches for either name refer to the same asset.
The Phase 1 trial NCT01421212 was an uncontrolled pilot study, not randomized and not double blinded. It enrolled 30 patients aged 18 years and older, of all sexes, and did not use biomarker-based patient selection. The study has completed.