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Completed

NCT Number: NCT00542997

Study of Subcutaneous Immune Globulin in Patients 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

Common Variable Immunodeficiency Agammaglobulinemia, non-Bruton type Autosomal Recessive Agammaglobulinemia Bruton type agammaglobulinemia Immune System Diseases Immunologic Deficiency Syndromes X-linked Agammaglobulinemia

Age range

2 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Study site, Paris, France

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About this study

This study consisted of a 12-week wash-in/wash-out period followed by a 28-week efficacy period. During the 28-week efficacy period, subjects visited the study site at least every 4 weeks for efficacy and safety evaluations and additionally recorded details regarding IgPro20 dose and certain aspects of efficacy and safety in a diary. Pharmacokinetic (PK) parameters were assessed in a sub-group of subjects during 1 treatment interval at steady-state (Week 28 ± 1).

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, namely with a diagnosis of Common Variable Immunodeficiency (CVID) as defined by the Pan-American Group for Immunodeficiency (PAGID) and European Society for Immunodeficiencies (ESID), X-linked agammaglobulinemia (XLA) as defined by PAGID and ESID, or Autosomal Recessive Agammaglobulinemia
  • Chest X-ray or CT scan obtained within 1 year prior to enrolment

Exclusion criteria

  • Newly diagnosed PID, i.e. subjects who have not previously received immunoglobulin replacement therapy
  • 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
  • Allergic or other severe reactions to immunoglobulins or other blood products associated with high anti-IgA

Additional criteria may apply and examination by an investigator is required to determine eligibility.

Treatment and study plan

Human Normal Immunoglobulin for Subcutaneous Administration (IGSC)

Biological

IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. The initial weekly dose was determined based on subjects' previous treatment. Dose adjustments could be performed during the wash-in/wash-out period at the discretion of the investigator.

Other names: Hizentra, SCIG

Primary outcomes

  1. Total Serum IgG Trough Levels

    Time frame: Up to 6 months prior to first IgPro20 treatment (Pre-study treatment) and Week 12 to 17 (IgPro20 treatment)

    Total IgG trough levels for IgPro20 treatment at steady state were compared with documented trough level data for IgG treatment received prior to enrolling in the study (either subcutaneous or intravenous IgG). For this purpose, 6 consecutive IgPro20 trough values (obtained prior to infusions 12 to 17) per subject were aggregated to the subject's median value and then median values across subjects were summarised using descriptive statistics. The same procedure was applied to pre-study treatment using the 3 most recent IgG trough values ≥ 5 g/L obtained prior to the first IgPro20 infusion.

Secondary outcomes

  1. Annual Rate of Clinically Documented Serious Bacterial Infections (ITT Population)

    Time frame: Efficacy period: week 12 to week 40 after study start or to the completion visit

    Serious bacterial infections (SBIs) included bacterial pneumonia, bacteraemia/septicaemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. Diagnosis of the SBIs was based on the presence of predefined clinical signs and symptoms as well as on laboratory parameters.

    The annual rate was calculated based on the total number of SBIs and the total number of study days during the efficacy period for all subjects in the ITT population and adjusted to 365 days.

  2. Annual Rate of Clinically Documented Serious Bacterial Infections (PPE Population)

    Time frame: Efficacy period: week 12 to week 40 after study start or to the completion visit

    Serious bacterial infections (SBIs) included bacterial pneumonia, bacteraemia/septicaemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. Diagnosis of the SBIs was based on the presence of predefined clinical signs and symptoms as well as on laboratory parameters.

    The annual rate was calculated based on the total number of SBIs and the total number of study days during the efficacy period for all subjects in the PPE population and adjusted to 365 days.

  3. Annual Rate of Infection Episodes

    Time frame: Efficacy period: week 12 to week 40 after study start or to the completion visit

    The annual rate of episodes was calculated based on the total number of any infection type and the total number of study days during the efficacy period for all subjects in the ITT population and adjusted to 365 days.

  4. Annual Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections

    Time frame: Efficacy period: week 12 to week 40 after study start or to the completion visit

    The annual rate was calculated based on the total number of days out of work/school/kindergarten/day care or unable to perform normal activities due to infections in the efficacy period divided by the total number of days in the efficacy period for all subjects and adjusted to 365 days.

  5. Annual Rate of the Number of Days of Hospitalization Due to Infections

    Time frame: Efficacy period: week 12 to week 40 after study start or to the completion visit

    The annual rate was calculated based on the total number of days of hospitalization due to infections in the efficacy period divided by the total number of days in the efficacy period for all subjects and adjusted to 365 days.

  6. Annual Rate of Antibiotic Use for Infection Prophylaxis and Treatment

    Time frame: Efficacy period: week 12 to week 40 after study start or to the completion visit

    The annual rate was calculated based on the total number of days of antibiotic use in the efficacy period divided by the total number of days in the efficacy period for all subjects and adjusted to 365 days.

Other outcomes

  1. Maximum Concentration (Cmax) of Total Serum IgG

    Time frame: Week 28 (±1week)

  2. Timepoint of Maximum Concentration (Tmax) of Total Serum IgG

    Time frame: Week 28 (±1week)

  3. Area Under the Concentration-Time Curve (AUC_last) of Total Serum IgG

    Time frame: Week 28 (±1week)

    AUC_last = Area under the concentration-time curve until last measured concentration.

  4. Area Under the Concentration-Time Curve (AUCτ) of Total Serum IgG

    Time frame: Week 28 (±1week)

    AUCτ = Area under the concentration-time curve during regular dosing interval;

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 12, 2007
Registry last updated
Sep 1, 2011

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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