Evaluation of the Efficacy and Safety of Flebogamma 5% DIF [Immune Globulin Intravenous (Human)] for Replacement Therapy in Pediatric Subjects With Primary Immunodeficiency Diseases.

NCT00634569 Phase 4 COMPLETED Results posted

This is a multi-center, open-label study to assess the efficacy and safety of Flebogamma 5% DIF in the pediatric population.

Details

Lead sponsor	Instituto Grifols, S.A.
Phase	Phase 4
Status	COMPLETED
Enrolment	24
Start date	2008-05
Completion	2011-05

Conditions

• Primary Immune Deficiency Disease

Interventions

• Flebogamma 5% DIF

Primary outcomes

• Serious Bacterial Infections. — 12 months
  Total number of Bacterial pneumonia, bacteremia or sepsis, osteomyelitis/septic arthritis, visceral abscess or bacterial meningitis

Countries

United States