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

CSL Behring

Status and phase

Completed

Phase 3

Conditions

Primary Immune Deficiency

Treatments

Biological: Immune globulin subcutaneous (Human)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01461018

IgPro20_3006

Details and patient eligibility

About

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).

Enrollment

22 patients

Sex

All

Ages

Under 75 years old

Volunteers

No Healthy Volunteers

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.