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NCT Number: NCT01461018

Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study)

The purpose of this study is to assess the long-term efficacy, tolerability, and safety of IgPro20 in subjects with primary immunodeficiency (PID) as an extension to the preceding follow-up study ZLB07_001CR (NCT01458171).

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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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects who have completed the preceding follow-up study ZLB07_001CR.
  • Written informed consent by the subject/parent/legally acceptable representative. Written assent for an underage subject (≥7 years and <20 years of age at the time of obtaining informed consent), according to the competencies of the subject.

Exclusion criteria

  • Pregnancy or nursing mother.
  • Participation in a study with an investigational medicinal product (IMP) within 3 months prior to enrollment except for study ZLB07_001CR.
  • Subjects who are planning to donate blood during the study.
  • Known or suspected antibodies to the IMP, or to excipients of the IMP.
  • Treatment with another immunoglobulin G (IgG) within 3 months prior to the study.

Treatment and study plan

Immune globulin subcutaneous (Human)

Biological

IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use.

Other names: Hizentra

Primary outcomes

  1. Annualized rate of infection episodes

    Time frame: Up to 36 months

Secondary outcomes

  1. Number of subjects with adverse events (AEs)

    Time frame: Up to 36 months

  2. Percentage of subjects with adverse events (AEs)

    Time frame: Up to 36 months

  3. Rate of AEs per infusion

    Time frame: Up to 36 months

  4. Annualized rate of clinically documented serious bacterial infections (SBIs)

    Time frame: Up to 36 months

    SBIs are defined as bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess.

  5. Number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections

    Time frame: Up to 36 months

  6. Number of days of hospitalization due to infections

    Time frame: Up to 36 months

  7. Duration of use of antibiotics for infection prophylaxis and treatment

    Time frame: Up to 36 months

  8. Median serum IgG concentration

    Time frame: Up to 36 months

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study title

A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects With Primary Immunodeficiency

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 27, 2011
Registry last updated
Dec 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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