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

PHASE3CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

July 31, 2009

Study Completion Date

July 31, 2009

Conditions
Primary Immune Deficiency Disorders (PIDD)
Interventions
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.

Trial Locations (17)

14222

Women's and Children's Hospital of Buffalo, Buffalo

20902

Institute For Allergy & Asthma, Wheaton

30060

Marietta Pulmonary Medicine, Marietta

33408

Allergy Associates of the Palm Beaches, North Palm Beach

35294

University of Alabama, Birmingham

41701

Kentuky Lung Clinic, PSC, Hazard

44103

University Hospital Case medical center, Cleveland

46617

South Bend Clinic LLP, South Bend

60612

Rush University Medical center, Chicago

63104

Cardinal Glennon Children's MC, St Louis

75063

Allergy, Asthma & Immunology Clinic, PA, Irving

75230

Allergy/Immunology Research Center of north Texas, Dallas

75231

AARA Research, Dallas

80112

1st Allergy and Clinical Resaerch center, Centennial

85032

Precision Trials LLC, Phoenix

90027

Children's Hospital of Los Angeles, Los Angeles

98225

Bellingham Asthma, Allergy Clinic, Bellingham

Sponsors
All Listed Sponsors
lead

ADMA Biologics, Inc.

INDUSTRY