Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...