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

CSL Behring

Status and phase

Completed

Phase 3

Conditions

Primary Immune Deficiency Disorder

Treatments

Biological: Immune globulin subcutaneous (Human)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01458171

ZLB07_001CR

Details and patient eligibility

About

The objective of this study is to assess the long-term safety, tolerability, and efficacy of IgPro20 in subjects with primary immunodeficiency (PID) as a follow-up to the pivotal study ZLB06_002CR (NCT01199705).

Enrollment

23 patients

Sex

All

Ages

Under 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects who have participated in study ZLB06_002CR and who have tolerated IgPro20 well.
Written informed consent by the subject/parent/legally acceptable representative. Written assent for an underage subject (≥7 years at the time of obtaining informed consent), as far as possible.

Exclusion criteria

Ongoing serious bacterial infections (SBIs) (pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time of the first infusion.
Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (known total urine protein concentration >0.2 g/L or urine protein ++ by dipstick).
Pregnancy or nursing mother.
Participation in a study with an investigational medicinal product (IMP) within 3 months prior to enrollment except for ZLB06_002CR.
Subjects who are planning to donate blood during the study.
Re-entry of subjects previously participating in the current follow-up study.
Known or suspected antibodies to the IMP, or to excipients of the IMP.