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Completed

NCT Number: NCT00719680

Extension Study of Subcutaneous Immunoglobulin Human in Patients With Primary Immunodeficiency (PID)

The purpose of this study is to determine whether a long-term use of a new human immunoglobulin G with proline (IgPro) is safe and effective in the treatment of primary immunodeficiency.

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Key information

Conditions

Primary Immune Deficiency Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases

Age range

2 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Contact CSL Behring for facility details, Centennial, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with primary humoral immunodeficiency who have participated in the study ZLB04_009CR (NCT00419341), namely with a diagnosis of Common Variable Immunodeficiency (CVID) as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies) or X-linked Agammaglobulinemia (XLA) as defined by PAGID and ESID
  • Women of childbearing potential must be using and agree to continue using medically approved contraception and must have a negative pregnancy test at screening
  • Written informed consent

Exclusion criteria

  • Ongoing serious bacterial infection at the time of screening
  • Malignancies of lymphoid cells such as lymphocytic leukemia, Non-Hodgkin's lymphoma, and immunodeficiency with thymoma
  • Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined by total urine protein concentration > 0.2 g/L)
  • Other significant medical conditions that could increase the risk to the patient
  • Females who are pregnant, breast-feeding or planning a pregnancy during the course of the study
  • A positive result at screening on any of the following viral markers: Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) or Hepatitis B virus (HBV)
  • Aspartate aminotransferase (ASAT) or Alanine aminotransferase (ALAT) concentration > 2.5 times Upper Normal Limit (UNL) at Completion Visit of study ZLB04_009CR (NCT00419341)
  • Creatinine concentration > 1.5 times UNL at Completion Visit of study ZLB04_009CR (NCT00419341)
  • Participation in a study with an investigational product other than IgPro20 within 3 months prior to enrollment
  • Evidence of uncooperative attitude
  • Any condition that is likely to interfere with evaluation of the study drug or satisfactory conduct of the trial
  • Subjects who are employees at the investigational site, relatives or spouse of the investigator

Treatment and study plan

IgPro20

Biological

Other names: IgG with Proline

Primary outcomes

  1. Annualized Rate of Serious Bacterial Infection (Intention-to-Treat Population)

    Time frame: For the duration of the study, up to approximately 104 weeks

    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. Annualized Rate of Serious Bacterial Infection (Per-Protocol Efficacy Population)

    Time frame: For the duration of the study, up to approximately 104 weeks

    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.

Secondary outcomes

  1. Annualized Rate of Any Infection

    Time frame: For the duration of the study, up to approximately 104 weeks

    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.

  2. Trough Levels of Total Immunoglobulin G (IgG) Serum Concentrations

    Time frame: Before infusion at Weeks 1, 24, 48, 72, and 96

    Mean of individual median total IgG trough concentration.

  3. Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection

    Time frame: For the duration of the study, up to approximately 104 weeks

  4. Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection

    Time frame: For the duration of the study, up to approximately 104 weeks

    The annualized rate was based on the total number of days out of work / school / kindergarten / day care or inability to perform normal activities due to infection, and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.

  5. Number of Days of Hospitalization Due to Infection

    Time frame: For the duration of the study, up to approximately 104 weeks

  6. Annualized Rate of Hospitalization Due to Infection

    Time frame: For the duration of the study, up to approximately 104 weeks

    The annualized rate was based on the total number of days of hospitalization due to infection and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.

  7. Use of Antibiotics for Infection Prophylaxis and Treatment

    Time frame: For the duration of the study, up to approximately 104 weeks

    Annualized rate of days with antibiotics for infection prophylaxis and treatment.

  8. Rate of All AEs by Relatedness and Severity

    Time frame: For the duration of the study, up to approximately 104 weeks

    The rate of AEs was the number of AEs over the number of infusions administered.

    At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.

    Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.

  9. Relatedness and Severity of All AEs (Percentage of Total AEs)

    Time frame: For the duration of the study, up to approximately 104 weeks

    At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.

    Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.

  10. Number of Subjects With Any Temporally Associated Adverse Event (AE) Within 24 or 72 Hours After an Infusion

    Time frame: Within 24 or 72 hours after each infusion

    AEs were considered temporally associated if they occurred between the start of infusion and within 24 or 72 hours after the end of infusion.

  11. Rate of Temporally Associated AEs Within 24 or 72 Hours of an Infusion

    Time frame: Within 24 or 72 hours after each infusion

    The rate of AEs was the number of AEs over the number of infusions administered.

    AEs were considered temporally associated if they occurred between the start of infusion and within 24 or 72 hours after the end of infusion.

  12. Number of Subjects Reporting Mild, Moderate, or Severe Local AEs

    Time frame: For the duration of the study, up to approximately 104 weeks

    In addition to the standard MedDRA System Organ Class (SOC) AE assignments, the category of 'local reactions' was defined to provide the possibility for a combined analysis of local reactions and included AEs of infusion site oedema, infusion site reaction, injection site pain, injection site rash, and injection site reaction.

    Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.

  13. Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Vital Signs

    Time frame: At weeks 1, 12, 24, 36, 48, 60, 72, 84, and 96

    Vital signs included blood pressure (systolic and diastolic), heart rate, and body temperature.

  14. Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Routine Laboratory Parameters

    Time frame: At Week 1, and study completion (approximately 104 weeks)

    Routine laboratory parameters included hematology, blood chemistry, and urinalysis parameters.

  15. Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Viral Safety Markers

    Time frame: At Week 1, and study completion (approximately 104 weeks)

    Viral safety markers included human immunodeficiency virus (HIV)-1, HIV-2, hepatitis A virus (HAV), HBV, HCV, and parvovirus B19.

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study title

A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency (PID)

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 22, 2008
Registry last updated
Apr 2, 2014

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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