Clinical Trial: Safety and Efficacy Study of Flebogamma 5% DIF IGIV in Pediatric Subjects

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary:
Sponsor: Instituto Grifols, S.A.

Current Primary Outcome: Serious Bacterial Infections. [ Time Frame: 12 months ]

Total number of Bacterial pneumonia, bacteremia or sepsis, osteomyelitis/septic arthritis, visceral abscess or bacterial meningitis


Original Primary Outcome: Number of Serious Bacterial Infections. [ Time Frame: 12 months ]

Current Secondary Outcome:

  • Days of School/Usual Activities Missed Per Year [ Time Frame: 12 months ]
    Mean Days of school/usual activities missed per subject/year
  • Days of Hospitalization Per Year [ Time Frame: 12 months ]
    Mean Days of hospitalization per subject/year
  • Number of Visits to Physician/ER Room for Acute Problems [ Time Frame: 12 months ]
    Mean Number of visits to physician/ER room for acute problems
  • Other Infections Documented by Fever and Physical Exam or Positive Radiograph. [ Time Frame: 12 months ]
  • Number of Infectious Episodes Per Year [ Time Frame: 12 months ]
    Mean Number of infectious episodes per subject/year
  • Number of Days on Antibiotics (Prophylactic and Therapeutic). [ Time Frame: 12 months ]
    Median Combined number of days on prophylactic and therapeutic antibiotics
  • Number of Adverse Events [ Time Frame: 12 months ]
    Total Number of Adverse Events


Original Secondary Outcome:

  • Days of School/Usual Activities Missed Per Year [ Time Frame: 12 months ]
  • Days of Hospitalization Per Year [ Time Frame: 12 months ]
  • Number of Visits to Physician/ER Room for Acute Problems [ Time Frame: 12 months ]
  • Other Infections Documented by Fever and Physical Exam or Positive Radiograph. [ Time Frame: 12 months ]
  • Number of Infectious Episodes Per Year [ Time Frame: 12 months ]
  • Number of Days on Antibiotics (Prophylactic and Therapeutic). [ Time Frame: 12 months ]
  • Number and percent of Adverse Events [ Time Frame: 12 months ]


Information By: Grifols Biologicals Inc.

Dates:
Date Received: March 5, 2008
Date Started: May 2008
Date Completion:
Last Updated: December 7, 2016
Last Verified: December 2016