Clinical Trial: Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy

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

Official Title: A Multicentre Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency

Brief Summary: The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).

Detailed Summary: This study consisted of a 12-week wash-in/wash-out period followed by a 28-week efficacy period. During the 28-week efficacy period, subjects visited the study site at least every 4 weeks for efficacy and safety evaluations and additionally recorded details regarding IgPro20 dose and certain aspects of efficacy and safety in a diary. Pharmacokinetic (PK) parameters were assessed in a sub-group of subjects during 1 treatment interval at steady-state (Week 28 ± 1).
Sponsor: CSL Behring

Current Primary Outcome: Total Serum IgG Trough Levels [ Time Frame: Up to 6 months prior to first IgPro20 treatment (Pre-study treatment) and Week 12 to 17 (IgPro20 treatment) ]

Total IgG trough levels for IgPro20 treatment at steady state were compared with documented trough level data for IgG treatment received prior to enrolling in the study (either subcutaneous or intravenous IgG). For this purpose, 6 consecutive IgPro20 trough values (obtained prior to infusions 12 to 17) per subject were aggregated to the subject's median value and then median values across subjects were summarised using descriptive statistics. The same procedure was applied to pre-study treatment using the 3 most recent IgG trough values ≥ 5 g/L obtained prior to the first IgPro20 infusion.


Original Primary Outcome: Total Serum IgG Trough Levels

Current Secondary Outcome:

  • Annual Rate of Clinically Documented Serious Bacterial Infections (ITT Population) [ Time Frame: Efficacy period: week 12 to week 40 after study start or to the completion visit ]

    Serious bacterial infections (SBIs) included bacterial pneumonia, bacteraemia/septicaemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. Diagnosis of the SBIs was based on the presence of predefined clinical signs and symptoms as well as on laboratory parameters.

    The annual rate was calculated based on the total number of SBIs and the total number of study days during the efficacy period for all subjects in the ITT population and adjusted to 365 days.

  • Annual Rate of Clinically Documented Serious Bacterial Infections (PPE Population) [ Time Frame: Efficacy period: week 12 to week 40 after study start or to the completion visit ]

    Serious bacterial infections (SBIs) included bacterial pneumonia, bacteraemia/septicaemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. Diagnosis of the SBIs was based on the presence of predefined clinical signs and symptoms as well as on laboratory parameters.

    The annual rate was calculated based on the total number of SBIs and the total number of study days during the efficacy period for all subjects in the PPE population and adjusted to 365 days.

  • Annual Rate of Infection Episodes [ Time Frame: Efficacy period: week 12 to week 40 after study start or to the completion visit ]
    The annual rate of episodes was calculated based on the total number of any infection type and the total number of study days during the efficacy period for all subjects in the ITT population and adjusted to 365 days.
  • Annual Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections [ Time Frame: Efficacy period: week 12 to week 40 after study start or to the completion visit ]
    The annual rate was calculated based on the total number of days out of work/school/kindergarten/day care or unable to perform normal activities due to infections in the efficacy period divided by the total number of days in the efficacy period for all subjects and adjusted to 365 days.
  • Annual Rate of the Number of Days of Hospitalization Due to Infections [ Time Frame: Efficacy period: week 12 to week 40 after study start or to the completion visit ]
    The annual rate was calculated based on the total number of days of hospitalization due to infections in the efficacy period divided by the total number of days in the efficacy period for all subjects and adjusted to 365 days.
  • Annual Rate of Antibiotic Use for Infection Prophylaxis and Treatment [ Time Frame: Efficacy period: week 12 to week 40 after study start or to the completion visit ]
    The annual rate was calculated based on the total number of days of antibiotic use in the efficacy period divided by the total number of days in the efficacy period for all subjects and adjusted to 365 days.


Original Secondary Outcome:

  • Rate of clinically documented serious bacterial infections
  • Number of infection episodes
  • Use of antibiotics for infection prophylaxis and treatment
  • Adverse events


Information By: CSL Behring

Dates:
Date Received: October 11, 2007
Date Started: September 2007
Date Completion:
Last Updated: August 2, 2011
Last Verified: August 2011