NCT00161993View on ClinicalTrials.gov

Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia)

PHASE2CompletedINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

June 13, 2002

Primary Completion Date

September 24, 2003

Study Completion Date

September 24, 2003

Conditions

Primary Immunodeficiency Diseases (PID)AgammaglobulinemiaHypogammaglobulinemia

Interventions

DRUG

Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution

DRUG

Gammagard S/D (Solvent/Detergent)

Trial Locations (6)

41345

SU/Sahlgrenska, Gothenburg

33 521

Tampere University Hospital, Tampere

205 20

Turku University Central Hospital, Turku

221 85

University Hospital Lund, Lund

205 02

University Hospital MAS, Malmo

851 86

Sundsvall Hospital, Sundsvall

All Listed Sponsors

lead

Baxalta now part of Shire

INDUSTRY

NCT00161993 - Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia) | Biotech Hunter | Biotech Hunter