NCT04565015View on ClinicalTrials.gov

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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

December 21, 2020

Primary Completion Date

May 31, 2026

Study Completion Date

November 30, 2026

Conditions
Primary Immune Deficiency
Interventions
BIOLOGICAL

GC5107

Intravenously infused at a dose of 300 - 900 mg per kg (of body weight) every 21 or 28 days for 12 months

Trial Locations (8)

21000

Institute for Child and Youth Health Care of Vojvodina, Novi Sad

22030

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

23219

Children's Hospital of Richmond at VCU, Richmond

71000

University Clinical Center Sarajevo, Sarajevo

75000

University clinical center Tuzla, Tuzla

75230

Allergy Partners of North Texas Research, Dallas

80045

Children's Hospital Colorado, Aurora

80112

Immunoe Health & Research Centers, Centennial

Sponsors

Lead Sponsor

GC Biopharma Corp

Collaborators (1)

Atlantic Research Group
All Listed Sponsors
collaborator

Atlantic Research Group

OTHER

lead

GC Biopharma Corp

INDUSTRY

NCT04565015 - Study of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency | Biotech Hunter | Biotech Hunter