Trial record 13 of 28 for:    "Common Variable Immunodeficiency" OR "common variable immune deficiency"

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT00322556
First received: May 5, 2006
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Agammaglobulinemia
IgG Deficiency
Common Variable Immunodeficiency
Drug: Immunoglobulins Intravenous (Human)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Extension Study on the Safety and Efficacy of IgPro10 in Patients With Primary Immunodeficiency (PID)

Resource links provided by NLM:


Further study details as provided by CSL Behring:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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. ] [ Designated as safety issue: Yes ]
    Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.


Secondary Outcome Measures:
  • Annualized Rate of Acute Serious Bacterial Infections. [ Time Frame: For the duration of the study, up to approximately 29 months ] [ Designated as safety issue: No ]

    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. ] [ Designated as safety issue: No ]
  • Number of Days of Hospitalization. [ Time Frame: For the duration of the study, up to approximately 29 months ] [ Designated as safety issue: No ]
  • Annualized Rate of Any Infection. [ Time Frame: For the duration of the study, up to approximately 29 months. ] [ Designated as safety issue: Yes ]

    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. ] [ Designated as safety issue: No ]
    Mean IgG trough concentration. For this analysis, each subject's values were first aggregated to their median and the median values were then analyzed.


Enrollment: 55
Study Start Date: November 2005
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IgPro10
See Intervention Description
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

  Eligibility

Ages Eligible for Study:   4 Years to 71 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00322556

Locations
United States, California
Contact CSL Behring for facility details
Los Angeles, California, United States, 90027
United States, Colorado
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Centennial, Colorado, United States, 80112
United States, Florida
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North Palm Beach, Florida, United States, 33408
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St. Petersburg, Florida, United States, 33701
United States, Indiana
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Fort Wayne, Indiana, United States, 46815
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Indianapolis, Indiana, United States, 46202
United States, Iowa
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Iowa City, Iowa, United States, 52242
United States, Minnesota
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Rochester, Minnesota, United States, 55905
United States, Missouri
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St. Louis, Missouri, United States, 63104-1095
United States, Texas
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Dallas, Texas, United States, 75230
Sponsors and Collaborators
CSL Behring
Investigators
Study Director: Program Coordinator CSL Behring
  More Information

Additional Information:
Publications:
Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT00322556     History of Changes
Other Study ID Numbers: ZLB05_006CR
Study First Received: May 5, 2006
Results First Received: September 27, 2012
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by CSL Behring:
Immunoglobulin Intravenous
Agammaglobulinemia
Hypogammaglobulinemia
Common variable immunodeficiency
Immunoglobulin G
Children

Additional relevant MeSH terms:
Common Variable Immunodeficiency
Agammaglobulinemia
Immunologic Deficiency Syndromes
IgG Deficiency
Blood Protein Disorders
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immune System Diseases
Dysgammaglobulinemia
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014