NCT00782106View on ClinicalTrials.gov

Study to Determine the Dose of Recombinant Human Hyaluronidase Needed to Infuse a Full Dose of IGIV Subcutaneously

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

December 4, 2006

Primary Completion Date

November 1, 2007

Study Completion Date

November 1, 2007

Conditions
Primary Immunodeficiency Diseases (PID)
Interventions
BIOLOGICAL

Recombinant human hyaluronidase + immune globulin intravenous

Dose (calculated) of rHuPH20 followed by subcutaneous infusion of IGIV, 10% to determine tolerability: doses of rHuPH20 and IGIV, 10% to be increased, as tolerated and as per protocol, until a full 4-week IgG dose can be administered

BIOLOGICAL

Recombinant human hyaluronidase + immune globulin intravenous

"1. IV infusion of IGIV, 10% to determine pharmacokinetics~2. Intervention as in Arm 1: Dose (calculated) of rHuPH20 followed by subcutaneous infusion of IGIV, 10% to determine tolerability: doses of rHuPH20 and IGIV, 10% to be increased, as tolerated and as per protocol, until a full 4-week IgG dose can be administered"

Trial Locations (3)

33408

Allergy Associates of the Palm Beaches, North Palm Beach

75230

Pediatrics Allergy/Immunology Association, PA, Dallas

80112

First Allergy and Clinical Research Center, Centennial

All Listed Sponsors
lead

Baxalta now part of Shire

INDUSTRY

NCT00782106 - Study to Determine the Dose of Recombinant Human Hyaluronidase Needed to Infuse a Full Dose of IGIV Subcutaneously | Biotech Hunter | Biotech Hunter