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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00322556
First Posted: May 8, 2006
Last Update Posted: October 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
CSL Behring
May 5, 2006
May 8, 2006
September 27, 2012
October 26, 2012
October 26, 2012
November 2005
April 2008   (Final data collection date for primary outcome measure)
  • 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.

  • Number of Subjects With Clinically Significant Changes in Vital Signs. [ Time Frame: Before, during, and after each infusion. ]
    Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.
  • 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
Complete list of historical versions of study NCT00322556 on ClinicalTrials.gov Archive Site
  • 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.
  • 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
Not Provided
Not Provided
 
Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
A Multicenter Extension Study on the Safety and Efficacy of IgPro10 in Patients With Primary Immunodeficiency (PID)
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.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Agammaglobulinemia
  • IgG Deficiency
  • Common Variable Immunodeficiency
Drug: Immunoglobulins Intravenous (Human)
Liquid formulation; treatment schedule every 3 or 4 weeks using an individualized regimen with a dose of 0.2 - 0.8 g IgG per kg bw
Experimental: IgPro10
See Intervention Description
Intervention: Drug: Immunoglobulins Intravenous (Human)
Sleasman JW, Duff CM, Dunaway T, Rojavin MA, Stein MR. Tolerability of a new 10% liquid immunoglobulin for intravenous use, Privigen, at different infusion rates. J Clin Immunol. 2010 May;30(3):442-8. doi: 10.1007/s10875-010-9373-x. Epub 2010 Mar 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
April 2008
April 2008   (Final data collection date for primary outcome measure)

Key Inclusion Criteria:

Patients with CVID (Common Variable Immunodeficiency) or XLA (X-linked agammaglobulinemia) who:

Participated in the Phase III clinical study with intravenous IgPro10 (study number ZLB03_002CR) at 3- or 4- weekly intervals for 12 months (referred to as 'old' subjects)

OR

Were ≥ 6 years of age, were on other stable intravenous immunoglobulin therapy (200-800 mg IgG per kg body weight) at 3- or 4-week intervals for at least 6 months, AND were interested in participating in the Phase III clinical study with subcutaneous IgPro20 (study number ZLB04_009CR) (referred to as 'new' subjects)

Written informed consent

Key Exclusion Criteria:

Diagnosis of epilepsia

Insulin dependent diabetes

Administration of steroids (daily ≥ 0.15 mg prednisone equivalent/kg/day) or other immunosuppressive drugs

History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure, severe hypertension

Sexes Eligible for Study: All
4 Years to 71 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00322556
ZLB05_006CR
Not Provided
Not Provided
Not Provided
CSL Behring
CSL Behring
Not Provided
Study Director: Program Coordinator CSL Behring
CSL Behring
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP