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Completed

NCT Number: NCT00322556

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

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Key information

Conditions

Agammaglobulinemia Blood Protein Disorders Common Variable Immunodeficiency Dysgammaglobulinemia Hematologic Diseases Hemic and Lymphatic Diseases IgG Deficiency Immune System Diseases Immunologic Deficiency Syndromes Lymphatic Diseases Lymphoproliferative Disorders

Age range

4 year–71 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Contact CSL Behring for facility details, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immunoglobulins Intravenous (Human)

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Number of Days of Hospitalization.

    Time frame: For the duration of the study, up to approximately 29 months

  4. 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".

  5. 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.

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
May 8, 2006
Registry last updated
Oct 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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