Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency

PHASE3CompletedINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

September 30, 2017

Study Completion Date

December 31, 2017

Conditions
Primary Immunodeficiency
Interventions
BIOLOGICAL

IGIV-C 10%

IGIV-C 10% infusions every 3 to 4 weeks based on previous IgG regimen

BIOLOGICAL

IGSC 20%

IGSC 20% weekly infusions with dose calculated based on previous IgG regimen

Trial Locations (25)

17033

Penn State University, Hershey

23298

Children's Hospital of Richmond at VCU, VCU Medical Center, Richmond

27710

Duke University Medical Center, Durham

30322

Emory Children's Center, Atlanta

33136

University of Miami - Batchelor Children's Research Institute, Miami

33408

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

33701

University of South Florida, St. Petersburg

46617

The South Bend Clinic, South Bend

48201

Children's Hospital of Michigan - Wayne State University, Detroit

55446

Midwest Immunology, Plymouth

60612

Rush University Medical Center, Chicago

63110

Washington University Medical Center, St Louis

73131

Oklahoma Institute of Allergy and Asthma Clinical Research, Oklahoma City

74136

Vital Prospects Clinical Research Institute, PC, Tulsa

75231

AARA Research Center, Dallas

77030

Baylor Texas Children's Hospital, Houston

78229

University of Texas Health Science Center at San Antonio, San Antonio

80206

National Jewish Health, Denver

90095

UCLA Medical Center, Los Angeles

90404

AIRE Medical of Los Angeles, Santa Monica

K1H 8L6

Ottawa Hospital, Division of Infectious Disease and Respirology, Ottawa

H3T 1C4

CHU Sainte-Justine, Montreal

H4A 3J1

McGill University Health Center, Montreal

G1V 4M6

Clinique d'asthme et d'allergie de Quebec, Québec

M5G 1X8

The Hospital for Sick Children, Toronto

Sponsors
All Listed Sponsors
lead

Grifols Therapeutics LLC

INDUSTRY

NCT02604810 - Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency | Biotech Hunter | Biotech Hunter