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Also known as Nabi-IGIV 10% [Immune Globulin Intravenous (Human). 10%]
Nabi-IGIV 10% · 1 trial · 1 indication
Serious bacterial infections (SBIs) rate per person-years, including bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia and visceral abscess.
| Arm | Type | Description |
|---|---|---|
| Nabi-IGIV Infused Every 3- or 4-Weeks | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Nabi-IGIV 10% [Immune Globulin Intravenous (Human). 10%] | BIOLOGICAL | Nabi-IGIV 10% \[Immune Globulin Intravenous (Human), 10%\] is a clear or slightly opalescent, colorless to pale yellow sterile solution of 10% protein concentration of immunoglobulin G (100mg/mL). It is packaged as 5g in 50mL solution and 10g in 100mL solution. Dosing will be 300-800 mg/kg based on subject's prior dosing history. Infusions will be every 3 or 4 weeks. |
Inclusion Criteria: * Male or female, age ≥ 6 and ≤ 75, with a documented and confirmed pre-existing diagnosis of chronic primary immune deficiency (PIDD) with a low total immunoglobulin G (IgG) level and deficient antibody production before chronic therapy (i.e., X-linked agammaglobulinemia, commo...
Nabi-IGIV 10% is an investigational immune globulin intravenous (human) product at a 10% concentration. It is being developed by ADMA Biologics Inc for the treatment of Primary Immune Deficiency Disorders, a group of conditions in which the immune system does not function properly. It is not yet approved.
Nabi-IGIV 10% is being studied as a replacement therapy for patients with Primary Immune Deficiency Disorders (PIDD). The goal is to supply immune globulin intravenously to patients whose immune systems do not produce adequate antibodies. The only trial of the product enrolled 63 subjects aged 6 years and older in the United States.
Nabi-IGIV 10% is developed by ADMA Biologics Inc, which trades on the Nasdaq under the ticker ADMA. The company is the sponsor of the clinical program for this immune globulin intravenous (human) 10% product.
Nabi-IGIV 10% has completed a Phase 3 clinical trial. It is an investigational product and is not approved by the FDA. The Phase 3 study, NCT00538915, has been completed, and no trials of the product are currently listed as active.
Nabi-IGIV 10% has been evaluated in one clinical trial, NCT00538915, titled an open label Phase III study of NABI-IGIV 10% in subjects with Primary Immune Deficiency Disorders. The trial was completed, enrolled 63 participants, was uncontrolled, and was conducted in the United States.
Yes. Nabi-IGIV 10% is also written as Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%]. The bracketed text describes the product type and concentration, so searches for either name refer to the same ADMA Biologics investigational product for Primary Immune Deficiency Disorders.