Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric PIDD Subjects

PHASE3CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

September 25, 2017

Primary Completion Date

July 20, 2022

Study Completion Date

July 20, 2022

Conditions
Primary Immunodeficiency Diseases (PID)
Interventions
BIOLOGICAL

HYQVIA

Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (IGI, 10% with rHuPH20)

Trial Locations (19)

11021

Northwell Health, Inc. PRIME, Great Neck

11794

Stony Brook Children's Hospital, Stony Brook

14203

Women & Children's Hospital of Buffalo, Buffalo

22030

Section on Immunopathogenesis and Clinical Immunology, Fairfax

25701

Marshall University Joan C. Edwards School of Medicine, Charleston

28203

Carolinas Healthcare System, Charlotte

28277

Allergy Asthma & Immunology Relief of Charlotte, Charlotte

30322

Emory Healthcare, Atlanta

31707

Georgia Pollens Clinical Research Centers, Inc., Albany

33136

University of Miami Pediatric Allergy and Immunology, Miami

33701

University of South Florida Physician Group, St. Petersburg

35294

University of Alabama Medical Center, Birmingham

63110

Washington University, St Louis

73131

OK Institute of Allergy & Asthma Clinical Research, LLC, Oklahoma City

74136

Vital Prospects Clinical Research Institute, P.C., Tulsa

75230

Allergy Partners of North Texas Research, Dallas

84132

University of Utah, Salt Lake City

06106

Connecticut Children's Medical Center, Hartford

02115

Boston Children's Hospital, Boston

All Listed Sponsors
collaborator

Baxalta Innovations GmbH, now part of Shire

INDUSTRY

lead

Baxalta now part of Shire

INDUSTRY

NCT03277313 - Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric PIDD Subjects | Biotech Hunter | Biotech Hunter