Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects

PHASE4CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

May 30, 2017

Primary Completion Date

January 15, 2021

Study Completion Date

January 15, 2021

Conditions
Primary Immunodeficiency Diseases (PID)
Interventions
BIOLOGICAL

HYQVIA

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

BIOLOGICAL

KIOVIG

100 mg/ml solution for Immune Globulin Intravenous Infusion

BIOLOGICAL

Cuvitru

200 mg/ml solution for Immune Globulin Subcutaneous Injection

Trial Locations (20)

2100

Rigshospitalet, Copenhagen

15006

FN v Motole Interni klinika, Prague

33076

Groupe Hospitalier Pellegrin - Hôpital des Enfants, Bordeaux

49033

CHU Angers - Hôpital Hôtel Dieu, Angers

61300

Fakultni nemocnice Brno Odd. Detska klinika, Brno

69008

Hospices Civils de Lyon - Hôpitaux Est - IHOP, Lyon

83340

1.Detská klinika, Bratislava

500 05

Fakultní nemocnice Hradec Králové, Nový Hradec Králové

115 27

Agia Sophia Children's Hospital, Athens

546 42

General Hospital of Thessaloniki Ippokrateio, Thessaloniki

564 03

General Hospital of Thessaloniki Papageorgiou, Thessaloniki

H-1097

United St. Istvan and St. Laszlo Hospital, Budapest

03659

Univerzitna Nemocnica Klinika detí a dorastu, Martin

416 85

Queen Silvia Children's Hospital, Gothenburg

221 85

Dept. of Pediatric Oncology/Hematology/Immunology-Skånes Universitetssjukhus, Lund

BS2 8BJ

Bristol Royal Hospital for Children, Bristol

LS1 3EX

Leeds Children's Hospital, Leeds

BT1 6DW

Royal Victoria Hospital, Belfast

CF14 4XW

University Hospital of Wales Heath Park Clinical Research Facility, Cardiff

NE7 7DN

The Great North Children's Hospital Royal Victoria Infirmary, Newcastle upon Tyne

All Listed Sponsors
collaborator

Baxalta Innovations GmbH, now part of Shire

INDUSTRY

lead

Baxalta now part of Shire

INDUSTRY

NCT03116347 - Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects | Biotech Hunter | Biotech Hunter