Study of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency

PHASE3CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

October 31, 2016

Primary Completion Date

July 31, 2019

Study Completion Date

July 31, 2019

Conditions
Immunologic Deficiency Syndromes
Interventions
BIOLOGICAL

GC5107

GC5107 20g/200mL, intravenously, dose of 300 - 900 mg/kg (of body weight) every 21 or 28 days for 12 months, a follow-up (3 or 4 weeks)

Trial Locations (20)

22030

Lysosomal Rare Disorder Research and Treatment Center, Inc., Fairfax

33408

Allergy Associates of Palm Beaches PA, North Palm Beach

43235

Optimed Infusions LLC, Columbus

55446

Midwest Immunology Clinic and Infusion Center, Plymouth

73131

Oklahoma Institute of Allergy Ashma and Immunology, Oklahoma City

75034

Pediatric Pulmonary Associates of North Texas, Frisco

75063

Allergy Asthma and Immunology Clinic PA, Irving

75230

Allergy Partners of North Texas Research, Dallas

75231

Allergy and Asthma Specialists, Dallas

80112

Immuno International Research Centers, Centennial

T6G 2V2

University of Alberta Hospital, Edmonton

L8S4K1

Hamilton Health Sciences Corporation, Hamilton

K7L 2V7

Queen's University - Kingston General Hospital (KGH), Kingston

K1H 8L6

The Ottawa Hospital, Ottawa

M4V 1R2

Gordon Sussman Clinical Research, Toronto

M5B 1W8

Saint Michael's Hospital, Toronto

H2W 1T8

Hotel Dieu de Montreal, Montreal

H3T 1C5

CHU Ste-Justine - University of Montreal, Montreal

H4A 3J1

McGill University Health Centre (MUHC) - The Montreal Children's Hospital, Montreal

G1V 4W2

Clinique Spécialisée en Allergie de la Capitale, Québec

Sponsors
All Listed Sponsors
collaborator

Parexel

INDUSTRY

collaborator

Atlantic Research Group

OTHER

lead

Green Cross Corporation

INDUSTRY