Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

August 31, 2009

Study Completion Date

August 31, 2009

Conditions
Common Variable ImmunodeficiencyX-linked AgammaglobulinemiaAutosomal Recessive Agammaglobulinemia
Interventions
BIOLOGICAL

Human Normal Immunoglobulin for Subcutaneous Administration (IGSC)

IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. The initial weekly dose was determined based on subjects' previous treatment. Dose adjustments could be performed during the wash-in/wash-out period at the discretion of the investigator.

Trial Locations (19)

3010

Study site, Bern

13353

Study site, Berlin

25123

Study site, Brescia

30625

Study site, Hanover

40001

Study site, Düsseldorf

41013

Study site, Seville

41685

Study site, Gothenburg

55131

Study site, Mainz

75743

Study site, Paris

79095

Study site, Freiburg im Breisgau

80337

Study site, Munich

300011

Study site, Timișoara

400162

Study site, Cluj-Napoca

04129

Study site, Leipzig

04-736

Study site, Warsaw

020393

Study site, Bucharest

08036

Study site, Barcelona

CF 14 4XW

Study site, Cardiff

NW3 2QG

Study site, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CSL Behring

INDUSTRY