Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)

PHASE3CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

November 12, 2012

Primary Completion Date

August 27, 2014

Study Completion Date

August 27, 2014

Conditions
Primary ImmunodeficiencyAgammaglobulinemiaHypogammaglobulinemiaAntibody Deficiency
Interventions
BIOLOGICAL

Kedrion IVIG 10%

Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months

Trial Locations (15)

14618

AAIR Research Center, Rochester

23298

Virginia Commonwealth University Health Systems, Richmond

30342

Family Allergy & Asthma Center, PC, Atlanta

33408

Allergy Associates of the Palm Beaches, North Palm Beach

43235

Optimed Research, LTD, Columbus

52242

University of Iowa Hospital and Clinics, Iowa City

55446

Midwest Immunology Clinic, Plymouth

60612

Rush University, Chicago

72202

Arkansas Children's Hospital, Little Rock

75230

Dallas Allergy Immunology Research, Dallas

75231

AARA Research Center, Dallas

99204

Marycliff Allergy Specialists, Spokane

M4V1R2

Gordon Sussman Clinical Research Inc., Toronto

M5G1E2

Pediatric & Adult Allergy & Clinical Immunology, Toronto

M5G1X8

The Hospital for Sick Children, Toronto

All Listed Sponsors
lead

Kedrion S.p.A.

INDUSTRY

NCT01581593 - Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID) | Biotech Hunter | Biotech Hunter