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Hepatitis B immune globulin · 1 trial · 2 indications
HBV recurrence is measured by seroconversion or reappearance of HBsAg and HBV DNA positivity
| Arm | Type | Description |
|---|---|---|
| Hepatitis B immune globulin | EXPERIMENTAL | Treatment group (newly liver transplanted subjects due to HBV induced liver disease) |
| Name | Type | Description |
|---|---|---|
| Hepatitis B immune globulin | DRUG | Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively. |
Inclusion Criteria: * Male or female. * Patients from 18 to 70 years of age (both included). * Serum HBV DNA-negative determined by DNA PCR-amplification assay just prior to anhepatic phase visit. * Serum HBeAg negative just prior to anhepatic phase visit. * Patients who are to undergo liver transp...
Hepatitis B immune globulin is used for the prevention of Hepatitis B virus recurrence in patients who have undergone orthotopic liver transplantation. It is being studied in the context of Hepatitis B and liver transplantation, with a completed Phase 3 clinical trial evaluating its efficacy and safety for this purpose.
Hepatitis B immune globulin is developed by Grifols, S.A., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GRFS. The company is conducting clinical development of this product for the prevention of Hepatitis B virus recurrence in liver transplant recipients.
Hepatitis B immune globulin is in Phase 3 clinical development. A Phase 3 trial has been completed, though the product remains investigational and has not been reported as approved. The completed trial assessed its efficacy and safety in preventing Hepatitis B virus recurrence in newly orthotopic liver transplant recipients.
Hepatitis B immune globulin has one completed Phase 3 clinical trial, registered as NCT01131065. The trial, titled 'Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients,' enrolled 15 participants in Italy and was an uncontrolled, non-randomized study.
Yes, Hepatitis B immune globulin is also known as Niuliva. The Phase 3 clinical trial NCT01131065 refers to the product as Niuliva® in its title, confirming that Niuliva is a brand name for Hepatitis B immune globulin developed by Grifols.