Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 used for Hepatitis B Virus Associated Liver Disease, specifically in patients undergoing liver transplantation. It is being studied in combination with lamivudine to assess its pharmacokinetics in this patient population. The drug is currently in Phase 1 clinical development.
Hepatitis B Immune Globulin is being developed by ADMA Biologics Inc, a biopharmaceutical company traded under the ticker ADMA. The company is conducting clinical trials to evaluate the drug's use in patients with Hepatitis B Virus Associated Liver Disease.
Hepatitis B Immune Globulin is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug is not currently in active clinical trials.
Hepatitis B Immune Globulin has one completed clinical trial, NCT01421212, titled 'Pilot Study to Assess the Pharmacokinetics of Intravenous Nabi 5% Hepatitis B Immune Globulin (Boca HBVIg) Used in Combination With Lamivudine for Patients With Hepatitis B Virus (HBV) Associated Liver Disease Undergoing Liver Transplantation.' This Phase 1 trial enrolled 30 participants in the United States.
Yes, Hepatitis B Immune Globulin is a monoclonal antibody. It is being developed as a therapeutic option for Hepatitis B Virus Associated Liver Disease. The drug is administered intravenously and is currently in Phase 1 clinical trials.