NCT00538915

Open Label, Phase III Study of NABI-IGIV 10% [Immune Globulin Intravenous(Human), 10%] In Subjects With Primary Immune Deficiency Disorders (PIDD)

Open Label, Phase III Safety, Efficacy, and Pharmacokinetic Study of NABI-IGIV 10% [Immune Globulin Intravenous (Human), 10%] in Subjects With Primary Immune Deficiency Disorders (PIDD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: ADMA Biologics, Inc. · Industry
• Sex: All
• Age: 6 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if NABI-IGIV (10%) \[Immune Globulin Intravenous (Human), 10%\] is safe and effective in preventing serious bacterial infections (SBIs) in the treatment of patients with primary immune deficiency disorders (PIDD) when compared to historical control data.

Conditions

• Primary Immune Deficiency Disorders (PIDD)

Interventions

Type	Name	Description
BIOLOGICAL	Nabi-IGIV 10% [Immune Globulin Intravenous (Human). 10%]	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.

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2007-10-03
• Last updated: 2021-07-30
• Results posted: 2012-03-26

Locations

17 sites across 1 country: United States