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

CSL Behring22 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Immune Deficiency

Interventions

Immune globulin subcutaneous (Human)BIOLOGICAL

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

Eligibility

Sex: ALLMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (9)

Study site

Nagoya, Aichi Pref., Japan

Study site

Chiba, Chiba Pref., Japan

Study site

Fukuoka, Fukuoka, Japan

Study site

Gifu, Gifu Pref., Japan

Outcomes

Primary Outcomes

Annualized rate of infection episodes

Time frame: Up to 36 months

Secondary Outcomes

Number of subjects with adverse events (AEs)

Time frame: Up to 36 months

Percentage of subjects with adverse events (AEs)

Time frame: Up to 36 months

Rate of AEs per infusion

Time frame: Up to 36 months

Annualized rate of clinically documented serious bacterial infections (SBIs)

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

Time frame: Up to 36 months

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

Number of days of hospitalization due to infections

Time frame: Up to 36 months

Duration of use of antibiotics for infection prophylaxis and treatment

Time frame: Up to 36 months

Median serum IgG concentration

Time frame: Up to 36 months

Data from ClinicalTrials.gov

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