Pharmacokinetics, Safety, and Tolerability of Subcutaneous GAMUNEX-C in Pediatric Subjects With Primary Immunodeficiency

PHASE4CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

October 31, 2013

Study Completion Date

October 31, 2013

Conditions
Primary Immunodeficiency
Interventions
BIOLOGICAL

GAMUNEX-C

GAMUNEX-C Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Intravenous Administration: 200-600 mg/kg per intravenous infusion every 3-4 weeks

BIOLOGICAL

GAMUNEX-C

GAMUNEX-C Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Subcutaneous Administration: weekly subcutaneous infusion at a mg/kg dose based on subject's intravenous dose and dosing interval x 1.37 conversion factor

Trial Locations (4)

19104

The Children's Hospital of Philadelphia, Philadelphia

33021

Joe DiMaggio Children's Hospital, Hollywood

80112

IMMUNOe International Research Centers, Centennial

90027

Childrens Hospital Los Angeles, Los Angeles

Sponsors
All Listed Sponsors
lead

Grifols Therapeutics LLC

INDUSTRY