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Also known as Specific intravenous anti-hepatitis B immunoglobulin
Specific anti-hepatitis B immunoglobulin · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| IGIV-HB Grifols | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Specific intravenous anti-hepatitis B immunoglobulin | DRUG | Monthly doses of 5000 IU administered intravenously during 6 consecutive months |
Inclusion Criteria: 1. Patients having undergone a liver transplantation due to liver disease associated with hepatitis B virus, at least 1 year before and no more than 5 years before inclusion in the study. 2. Patients who have required treatment with HBIG, or are receiving it at present. 3. Patie...
Specific anti-hepatitis B immunoglobulin is an investigational biologic developed by Grifols, S.A. (ticker GRFS) for chronic hepatitis B. It is being studied in patients who have received a liver transplant, where it is evaluated for serum levels and pharmacokinetics. It is also known as specific intravenous anti-hepatitis B immunoglobulin.
Specific anti-hepatitis B immunoglobulin is being studied in chronic hepatitis B, specifically in patients following liver transplantation. The single Phase 3 trial evaluated serum levels and pharmacokinetics of the new hepatitis B immune globulin in this transplant population. It is an investigational product and is not described as approved for this use.
Specific anti-hepatitis B immunoglobulin is developed by Grifols, S.A., which trades under the ticker GRFS. Grifols is the sponsor associated with the clinical development program for this hepatitis B immune globulin product.
Specific anti-hepatitis B immunoglobulin is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The program is investigational and remains in clinical development for chronic hepatitis B in the liver transplant setting.
Specific anti-hepatitis B immunoglobulin has been studied in one completed Phase 3 trial, NCT00838071, titled Evaluation of Serum Levels and Pharmacokinetics of a New Hepatitis B Immune Globulin Following Liver Transplantation. The trial enrolled 20 participants in Spain, included adults 18 years and older of all sexes, and was uncontrolled without randomization or blinding.
Yes. Specific intravenous anti-hepatitis B immunoglobulin is an alternative name for specific anti-hepatitis B immunoglobulin. Both names refer to the same Grifols, S.A. (GRFS) product studied in chronic hepatitis B following liver transplantation, so readers searching either name are looking at the same asset.