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Completed

NCT Number: NCT01199705

Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)

The objective of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics of a subcutaneous immune globulin (SCIG; IgPro20) in subjects with primary immunodeficiency (PID). In addition, the study will assess the health-related quality of life and pharmacoeconomic aspects related to treatment with IgPro20.

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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

Up to 75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Study site, Nagoya, Aichi Pref., Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of PID with hypo- or agammaglobulinemia requiring IgG replacement therapy
  • Intravenous IgG (IVIG) therapy at regular 3- or 4-week intervals at a stable dose for at least 3 doses prior to signing of informed consent
  • Written informed consent

Exclusion criteria

  • Newly diagnosed PID, i.e., subjects who have not previously received immunoglobulin replacement therapy
  • Ongoing serious bacterial infections (SBIs: pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time of screening
  • Ongoing or history of concomitant malignancies of lymphoid cells such as lymphocytic leukemia, non-Hodgkin's lymphoma, and immunodeficiency with thymoma
  • Allergic or other severe reactions to immunoglobulins or other blood products recorded in the past 3 months or at the time of screening
  • Pregnancy or nursing mother
  • A positive result at screening on any of the following viral markers: human immunodeficiency virus-1 (HIV-1), HIV-2, hepatitis C virus, or hepatitis B virus
  • Participation in a study with other investigational product during this study and within 3 months prior to screening
  • Subjects who donated blood (200 mL within one month or 400 mL within 3 months prior to screening), or planning to donate blood during the study

Treatment and study plan

Immune Globulin Subcutaneous (Human) (SCIG)

Biological

IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human SCIG. Subjects will receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment.

Other names: Hizentra

Primary outcomes

  1. IgG Trough Level

    Time frame: During IVIG period (IV 1, IV 2, IV 3) and during SCIG period at weeks 16, 20, and 24

    Geometric means of trough levels measured before 3 intravenous immunoglobulin (IVIG) infusions was compared with those of trough levels measured at steady-state for 3 subcutaneous immunoglobulin (SCIG) infusions (weeks 16, 20 and 24). The ratio of these geometric means was the primary outcome measure.

Secondary outcomes

  1. Number of Infection Episodes (Serious and Non-serious) by Study Period

    Time frame: Up to 36 weeks

    Number of infection episodes (serious and non-serious) presented by study period:

    • IVIG treatment: Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks; before being switched to SCIG treatment with IgPro20).
    • SCIG treatment (wash-in/wash-out; weeks 1 to 12): IgPro20 was administered subcutaneously with the first subcutaneous (SC) IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
    • SCIG treatment (efficacy; weeks 13 to 24): After the SCIG wash-in/wash-out treatment, subjects were treated with weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.

  2. Rate of Infection Episodes (Serious and Non-serious) by Study Period, PPS Population

    Time frame: Up to 36 weeks

    The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.

    Study periods:

    • IVIG treatment (up to 12 weeks)
    • SCIG IgPro20 treatment (wash-in/wash-out period) (12 weeks)
    • SCIG IgPro20 treatment (efficacy) (12 weeks)

  3. Rate of Infection Episodes (Serious and Non-serious) by Study Period, FAS Population

    Time frame: Up to 36 weeks

    The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.

    Study periods:

    • IVIG treatment (up to 12 weeks)
    • SCIG IgPro20 treatment (wash-in/wash-out period) (12 weeks)
    • SCIG IgPro20 treatment (efficacy) (12 weeks)

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

    Time frame: Up to 36 weeks

    Median number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).

  5. Number of Days of Hospitalization Due to Infections by Study Period

    Time frame: Up to 36 weeks

    Median number of days of hospitalization due to infections, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).

  6. Duration of Use of Antibiotics for Infection Prophylaxis and Treatment

    Time frame: Up to 36 weeks

    Median number of days of use of antibiotics for infection prophylaxis and/or treatment, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).

  7. Rate of All Adverse Events by Relatedness and Seriousness

    Time frame: For the duration of the study, up to 36 weeks

    The rate of adverse events (AEs) was the number of treatment-emergent AEs over the number of infusions administered. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.

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

    Time frame: For the duration of the study, up to 36 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 discomfort, infusion site erythema, infusion site haemorrhage, infusion site induration, infusion site inflammation, infusion site pain, infusion site pruritus, infusion site swelling, injection site erythema, injection site extravasation, injection site induration, injection site irritation, injection site pain, injection site pruritus, injection site swelling, and puncture site reaction.

    Mild AE: Symptoms are easily tolerated and there is no interference with daily activities; Moderate AE: Discomfort enough to cause some interference with daily activities; Severe AE: Incapacitating with inability to work or do usual activity.

Other outcomes

  1. Annualized Rate of Serious Bacterial Infections (SBIs), PPS Population

    Time frame: Up to 36 weeks

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

    Study periods:

    • IVIG treatment (up to 12 weeks)
    • SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks)
    • SCIG IgPro20 treatment (efficacy; 12 weeks)

  2. Annualized Rate of Serious Bacterial Infections (SBIs), FAS Population

    Time frame: Up to 36 weeks

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

    Study periods:

    • IVIG treatment (up to 12 weeks)
    • SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks)
    • SCIG IgPro20 treatment (efficacy; 12 weeks)

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 13, 2010
Registry last updated
Dec 12, 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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