Clinical Trial: Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Multicenter, Open-label, Historically Controlled, Phase III Study to Assess the Efficacy, Tolerability, Safety and Pharmacokinetics of Kedrion IVIG 10% in Adult and Pediatric Subjects With Primary Imm

Brief Summary: The purpose of this study is to determine whether Kedrion IVIG 10% (an immunoglobulin solution) is effective in treating Primary Immunodeficiency (PID).

Detailed Summary:

People with primary immunodeficiency diseases (PID) have a defective immune system and experience recurrent protozoal, bacterial, fungal and viral infections. Antibody deficiencies make up the largest group of PIDs.

The standard care for patients with PID is replacement immunoglobulin (a class of antibodies) solution. Prophylactic treatment with intravenous immunoglobulin (IVIG) solution has been shown to increase the time free from serious infection.

Kedrion IVIG 10% is a new preparation of an immunoglobulin G (IgG) solution. Kedrion IVIG 10% will be given by IV infusion to all study participants. The data collected will help determine whether Kedrion IVIG 10% is suitable for treating PID subjects.


Sponsor: Kedrion S.p.A.

Current Primary Outcome: Incidence of acute, serious bacterial infections [ Time Frame: 13 months ]

The incidence of acute serious bacterial infections, e.g. bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, visceral abscess.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of infections other than acute, serious bacterial infections [ Time Frame: 13 months ]
    The incidence of infections other than acute serious bacterial infections.
  • Evidence of change in daily activities due to infections [ Time Frame: 13 months ]
    • The number of days missed from work, school, kindergarten, day care, or days unable to perform normal daily activities due to infections.
    • Days of unscheduled physician visits and hospitalizations due to infection.
    • Days of therapeutic antibiotics.
  • IgG serum levels [ Time Frame: every month up to 13 months ]
    • IgG trough levels
    • Trough serum total IgG levels before each infusion of Kedrion IVIG 10% in all subjects and the interval between infusions will be recorded.
  • Incidence of adverse events [ Time Frame: 13 months ]
    • Overall incidence of adverse events that occur during or within 1 hour, 24 hours and 72 hours following an infusion of test product.
    • The proportion of adverse events considered by the investigator to be product related.
  • Incidence of decreased infusion rate due to adverse events [ Time Frame: 13 months ]
    The proportion and number of IVIG infusions for which the infusion rate was decreased due to adverse events.


Original Secondary Outcome: Same as current

Information By: Kedrion S.p.A.

Dates:
Date Received: April 16, 2012
Date Started: November 2012
Date Completion: August 2014
Last Updated: September 12, 2013
Last Verified: September 2013