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Completed

NCT Number: NCT00419341

Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy

The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).

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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

Study Site, Los Angeles, California, United States

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About this study

The entire study consists of a 12-week wash-in/wash-out period followed by a 12-month treatment period. Pharmacokinetic (PK) parameters were assessed in a sub-group of subjects.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female aged 2 to 75 years
  • Subjects with primary humoral immunodeficiency, namely with a diagnosis of: CVID (Common Variable Immunodeficiency) as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies) or XLA (X-linked Agammaglobulinemia)
  • Written informed consent

Exclusion criteria

  • Newly diagnosed PID
  • Evidence of an active serious infection at the time of screening (i.e., but not limited to: bacteremia/septicemia, pneumonia, fungal osteomyelitis)
  • Malignancies of lymphoid cells such as lymphocytic leukemia, Non-Hodgkin's lymphoma and immunodeficiency with thymoma
  • Known hyperprolinemia
  • Hypoalbuminemia, protein-losing enteropathies, and any proteinuria
  • Allergic reactions to immunoglobulins or other blood products
  • Known antibodies to Immunoglobulin A (IgA)
  • The subject is receiving steroids (oral and parenteral, daily ≥ 0.15 mg of prednisone equivalent/kg/day) or other systemic immunosuppressants
  • Female who is pregnant, breast feeding or planning a pregnancy during the course of the study
  • Participation in a study with an investigational product other than (IVIG) within 1 month prior to enrollment
  • A positive result at screening on any of the following viral markers: Human Immunodeficiency Virus (HIV), Hepatitis C virus (HCV) and Hepatitis B virus (HBV)
  • Aspartate aminotransferase (ASAT) or Alanine aminotransferase (ALAT) concentration > 2.5 times the upper normal limit (UNL)
  • Creatinine concentration > 1.5 times the UNL
  • Any condition that is likely to interfere with evaluation of the study drug or satisfactory conduct of the trial

Treatment and study plan

Human Normal Immunoglobulin for Subcutaneous Administration

Biological

Other names: Hizentra

Primary outcomes

  1. Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs) (MITT Population)

    Time frame: Efficacy period: up to 12 months (week 13 to the completion visit)

    The annualized rate was based on the total number of SBIs and the total number of subject study days during the efficacy period for all subjects in the specified analysis population and adjusted to 365 days.

    Potential SBIs included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an adverse event (AE) was identified as a potential SBI, the AE was adjudicated by a review committee to determine if the event fulfilled the predefined criteria for SBIs.

  2. Area Under the Concentration-time Curve (AUC) of Total Serum Immunoglobulin G (IgG)

    Time frame: Measured during a single dosing interval after at least 12 weeks of stable subcutaneous (SC) dosing with IgPro20 treatment

    Evaluate non-inferiority of steady-state IgG area under the concentration-time curves standardized to a 7-day period (sAUCs) for subcutaneous immunoglobulin (SCIG) (IgPro20) versus the sAUC under intravenous immunoglobulin (IVIG) (Privigen) treatment. The sAUC under IVIG was taken from the same subjects in a preceding study (either ZLB03_002CR [NCT00168025] or ZLB05_006CR [NCT00322556]).

Secondary outcomes

  1. Annualized Rate of Clinically Documented SBIs (ITT Population)

    Time frame: For the duration of the study, up to 15 months

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

    Potential SBIs included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an AE was identified as a potential SBI, the AE was adjudicated by a review committee to determine if the event fulfilled the predefined criteria for SBIs.

  2. Annualized Rate of Clinically Documented SBIs (PPE Population)

    Time frame: Efficacy period: up to 12 months (week 13 to the completion visit)

    The annualized rate was based on the total number of SBIs and the total number of subject study days during the efficacy period for all subjects in the specified analysis population and adjusted to 365 days.

    Potential SBIs included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an AE was identified as a potential SBI, the AE was adjudicated by a review committee to determine if the event fulfilled the predefined criteria for SBIs.

  3. Annualized Rate of Infection Episodes

    Time frame: Efficacy period: up to 12 months (week 13 to completion visit)

    The annualized rate was based on the total number of infection episodes occurring during the efficacy period (N = 96) divided by the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.

  4. Number of Infection Episodes (Serious and Non-serious)

    Time frame: Efficacy period: up to 12 months (week 13 to the completion visit)

    Total number of infections for the specified analysis population

  5. Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Daily Activities Due to Infections

    Time frame: Efficacy period: up to 12 months (week 13 to the completion visit)

    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 (N = 71), and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.

  6. Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Daily Activities Due to Infections

    Time frame: Efficacy period: up to 12 months (week 13 to the completion visit)

    Total number of days out of work / school / kindergarten / day care or unable to perform normal daily activities due to infections, for the specified analysis population

  7. Annualized Rate of Hospitalization Due to Infection

    Time frame: Efficacy period: up to 12 months (week 13 to the completion visit)

    The annualized rate was based on the total number of days of hospitalization due to infection (N = 7) and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.

  8. Number of Days of Hospitalization Due to Infections

    Time frame: Efficacy period: up to 12 months (week 13 to the completion visit)

    Total number of days of hospitalization due to infections for the specified analysis population

  9. Use of Antibiotics for Infection Prophylaxis and Treatment

    Time frame: Efficacy period: up to 12 months (week 13 to the completion visit)

    Annualized rate of days with antibiotics for infection prophylaxis and treatment. The annualized rate was based on the total number of days of antibiotic use for infection prophylaxis and treatment in the efficacy period, and the total number of subject study days for all subjects in the specified analysis population, and adjusted to 365 days.

  10. Total Serum IgG Trough Levels

    Time frame: Every 4 weeks, throughout the 12-month efficacy period

    The IgG trough values per subject were aggregated to a median value, and then median values across subjects were summarized using descriptive statistics.

  11. Maximum Concentration (Cmax) of Total Serum IgG at Steady State

    Time frame: Week 28 ± 1 week of the treatment period

  12. Tmax at Steady State

    Time frame: Week 28 ± 1 week of the treatment period

    Timepoint of maximum concentration (Cmax)

Other outcomes

  1. Minimum Concentration (Cmin) of Total Serum IgG at Steady State

    Time frame: Week 28 ± 1 week of the treatment period

  2. Rate of All AEs by Relatedness and Seriousness

    Time frame: For the duration of the study, up to 15 months

    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.

  3. Rate of Mild, Moderate, or Severe Local Reactions

    Time frame: For the duration of the study, up to 15 months

    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 injection site reaction, injection site bruising, infusion site scab, injection site cyst, injection site eczema, injection site irritation, injection site nodule, and injection site pain.

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

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study title

A Phase III Open-Label, Prospective, Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human), IgPro20 in Subjects With Primary Immunodeficiency (PID)

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 8, 2007
Registry last updated
Jan 25, 2013

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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