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

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ClinicalTrials.gov Identifier: NCT00322556
Recruitment Status : Completed
First Posted : May 8, 2006
Results First Posted : October 26, 2012
Last Update Posted : October 26, 2012
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Tracking Information
First Submitted Date  ICMJE May 5, 2006
First Posted Date  ICMJE May 8, 2006
Results First Submitted Date  ICMJE September 27, 2012
Results First Posted Date  ICMJE October 26, 2012
Last Update Posted Date October 26, 2012
Study Start Date  ICMJE November 2005
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2012)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 5, 2006)
  • 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
Change History Complete list of historical versions of study NCT00322556 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2012)
  • 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 Measures  ICMJE
 (submitted: May 5, 2006)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Agammaglobulinemia
  • IgG Deficiency
  • Common Variable Immunodeficiency
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: IgPro10
See Intervention Description
Intervention: Drug: Immunoglobulins Intravenous (Human)
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 27, 2012)
55
Original Enrollment  ICMJE
 (submitted: May 5, 2006)
35
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 71 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00322556
Other Study ID Numbers  ICMJE ZLB05_006CR
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CSL Behring
Study Sponsor  ICMJE CSL Behring
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Program Coordinator CSL Behring
PRS Account CSL Behring
Verification Date September 2012

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