NCT01485796View on ClinicalTrials.gov

Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

December 29, 2011

Primary Completion Date

January 1, 2013

Study Completion Date

January 1, 2013

Conditions
Primary Immunodeficiency Diseases (PID)
Interventions
BIOLOGICAL

Immune Globulin Infusion (Human), 10%

Subcutaneous administration will be used in Study Epochs 1 and 2.

BIOLOGICAL

Recombinant human hyaluronidase

rHuPH20 will be administered subcutaneously (SC) immediately before each SC IGI, 10% infusion, through the same needle, at a rate of 1 to 2 mL/min.

Trial Locations (10)

11501

Winthrop Allergy and Immunology, Mineola

15241

Allergy and Clinical Immunology Associates, Pittsburgh

33408

Allergy Associates of the Palm Beaches, PA, North Palm Beach

55446

Midwest Immunology, Plymouth

68046

Midlands Pediatrics PC, Papillion

70118

LSU Health Sciences Center & Children´s Hospital, New Orleans

73131

Oklahoma Institute of Allergy & Asthma Clinical Research, Oklahoma City

75063

Allergy, Asthma & Immunology Clinic PA, Irving

80233

IMMUNOe International Research Centers, Thornton

92697

University of California, Irvine, Irvine

All Listed Sponsors
lead

Baxalta now part of Shire

INDUSTRY

NCT01485796 - Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD | Biotech Hunter | Biotech Hunter