Clinical Trial: Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)

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

Official Title: A Multicenter Extension Study on the Safety and Efficacy of IgPro10 in Patients With Primary Immunodeficiency (PID)

Brief Summary: The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety, the number of infusions temporally associated with AEs, the rate, severity and relationship of all AEs and the vital sign changes during each infusion will be evaluated.

Detailed Summary:
Sponsor: CSL Behring

Current Primary Outcome:

• The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs). [ Time Frame: During each infusion, and within 48 or 72 hours after the end of each infusion. ]
  AEs were considered temporally-associated AEs if they occurred during the infusion or in the period from the start of the infusion until either 48 or 72 hours after the end of the infusion.
• Influence of Infusion Rate on Temporally-Associated AEs [ Time Frame: Within 72 hours after each infusion ]

  The total and most frequent (1% or more) number of infusions for which subjects experienced temporally-associated AEs occurring within 72 hours of infusion, by infusion rate (≤ 4 mg/kg/min, ≤ 8 mg/kg/min, and > 8 and ≤ 12 mg/kg/min).

  AEs were considered to be temporally-associated AEs if they occurred in the period from the start of the infusion until 72 hours after the end of the infusion.

• Rate of AEs by Severity and Relationship [ Time Frame: For the duration of the study, up to approximately 29 months ]

  The AE rate was the number of AEs over the number of infusions administered.

  Mild AEs: Did not interfere with daily activities; Moderate AEs: Interfered with routine daily activities; Severe AEs: Impossible to perform routine daily activities.

  At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.

• Numb
  
  

  Original Primary Outcome:

  • Safety endpoints: The proportion of infusions temporally (during infusion and within 48 hours
  • after the end of infusion) associated with one or more AEs
  • Influence of infusion rate on adverse events
  • Rate, severity and relationship of all AEs
  • Vital sign changes during each infusion
  
  
  

  Current Secondary Outcome:

  • Annualized Rate of Acute Serious Bacterial Infections. [ Time Frame: For the duration of the study, up to approximately 29 months ]

    The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.

    Acute serious bacterial infections included pneumonia, bacteremia / septicemia, osteomyelitis / septic arthritis, bacterial meningitis, and visceral abscess.

  • Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Illness. [ Time Frame: For the duration of the study, up to approximately 29 months. ]
  • Number of Days of Hospitalization. [ Time Frame: For the duration of the study, up to approximately 29 months ]
  • Annualized Rate of Any Infection. [ Time Frame: For the duration of the study, up to approximately 29 months. ]

    The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.

    Infections were classified as all AEs with the system organ class "infections and infestations" and AEs with the preferred term "conjunctivitis".

  • Trough Levels of Total Immunoglobulin (IgG) Serum Concentrations. [ Time Frame: Prior to each infusion; every 3 or 4 weeks depending upon the dosing schedule. ]
    Mean IgG trough concentration. For this analysis, each subject's values were first aggregated to their median and the median values were then analyzed.
  
  
  

  Original Secondary Outcome:

  • Efficacy endpoints: Rate of acute serious bacterial infections;
  • Number of days out of work / school / kindergarten / day care due to underlying PID
  • Number of days of hospitalization
  • Rate of any infections
  • Trough levels of total IgG serum concentrations
  
  
  Information By: CSL Behring
  

  Dates:
  Date Received: May 5, 2006
  Date Started: November 2005
  Date Completion:
  Last Updated: September 27, 2012
  Last Verified: September 2012