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

PHASE3CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

June 30, 2016

Primary Completion Date

May 15, 2019

Study Completion Date

May 15, 2019

Conditions
Primary Immunodeficiency
Interventions
BIOLOGICAL

IGSC 20%

Weekly administration of IGSC 20% via intravenous infusion

Trial Locations (23)

3050

Royal Melbourne Hospital, Parkville

4066

Wesley Medical Research, Auchenflower

4736

The Children's Memorial Health Institute, Warsaw

14004

Hospital Universitario Reina Sofia, Córdoba

20246

Universitätsklinikum Hamburg-Eppendorf, Hamburg

28040

Hospital Clinico San Carlos, Madrid

28041

Hospital 12 Octubre, Madrid

34295

CHU de Montpellier, Montpellier

41013

Hospital Virgen del Rocio, Seville

44137

Klinikum Dortmund gGmbH, Dortmund

50005

University Hospital, Hradec Králové

53757

Asklepios Klinik Sankt Augustin, Sankt Augustin

55131

University Hospital of Mainz, Mainz

04129

Children's Hospital at Municipal Hospital St. Georg, Leipzig

Unknown

United St Istvan and St Laszlo Hospital, Budapest

H-4400

Josa Andras County Hospital, Nyiregyháza

08025

Hospital Universitario Vall d'Hebron, Barcelona

08035

Vall d'Hebron University Hospital, Barcelona

08950

Hospital Universitari Sant Joan de Déu, Barcelona

SE-14186

Stockholm, Stockholm

CB2 0QQ

Addenbrooke's Hospital, Cambridge

E1 2ES

St Bartholomew's Hospital, London

PL6 8DH

Derriford Hospital, Plymouth

Sponsors
All Listed Sponsors
lead

Grifols Therapeutics LLC

INDUSTRY