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

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

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2014-003409-13-Outside-EU/EEA
Enrollment
22
Registered
2015-01-05
Start date
Unknown
Completion date
Unknown
Last updated
2015-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Immune Deficiency

Interventions

Trade Name: Hizentra® Pharmaceutical Form: Solution for injection INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: Human Normal Immunoglobulin Concentration unit: % (W/V) perce

Sponsors

CSL Behring
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Main Objective: 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;Secondary Objective: Not applicable;Primary end point(s): Annualized rate of infection episodes;Timepoint(s) of evaluation of this end point: Up to 36 months—

Secondary

MeasureTime frame
Timepoint(s) of evaluation of this end point: Up to 36 months;Secondary end point(s): - Number of subjects with adverse events (AEs) - Percentage of subjects with adverse events (AEs) - Rate of AEs per infusion - Annualized rate of clinically documented serious bacterial infections (SBIs) - Number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections - Number of days of hospitalization due to infections - Duration of use of antibiotics for infection prophylaxis and treatment - Median serum IgG concentration—

Countries

Japan

Contacts

Public ContactTrial Registration Co-ordinator

CSL Behring

clinicaltrials@cslbehring.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026