A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 51

Inclusion Criteria

· Male or female aged > 24 months and < 65 years
· Subjects with primary humoral immunodeficiency, namely with a diagnosis of
- CVID as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies (16))
- or XLA as defined by PAGID and ESID (16)
- or Autosomal Recessive Agammaglobulinemia
· Subjects who have received
- IVIG therapy at regular 3- or 4-week intervals
- or SCIG therapy at regular weekly intervals
at a stable dose (variations of ± 10% are allowed) for at least 6 months prior to receiving IgPro20 (maintenance dose to reach a cumulative monthly dose of the order of 0.2 – 0.8 g/kg)
· At least 3 documented IgG trough levels of = 5 g/L during 3 months on IVIG or SCIG replacement therapy immediately prior to receiving IgPro20; 2 of the 3 IgG trough levels may go back up to 6 months prior to receiving IgPro20, in case of stable dosing for at least 3 months prior to this assessment
· Chest X-ray or CT Scan obtained within 1 year prior to enrollment
· Women of childbearing potential using medically approved contraception and having a negative pregnancy test at screening
· Written informed consent

INCLUSION CRITERIA FOR PK SUBSTUDY
· Male or female aged = 6 years
· Written informed consent

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

· Newly diagnosed PID, i.e. subjects who have not previously received immunoglobulin replacement therapy
· Ongoing serious bacterial infection at the time of screening
· Malignancies of lymphoid cells such as lymphocytic leukemia, Non-Hodgkin’s lymphoma and immunodeficiency with thymoma
· Known hyperprolinemia
· Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined by total urine protein concentration > 0.2 g/L)
· Allergic or other severe reactions to immunoglobulins or other blood products associated with high anti-IgA
· The subject is receiving steroids (oral and parenteral, daily = 0.15 mg of prednisone equivalent/kg/day) or other systemic immunosuppressants
· Females who are pregnant, breast feeding or planning a pregnancy during the course of the study
· A positive result at screening on any of the following viral markers: HIV, HCV or HBV
· ASAT or ALAT concentration > 2.5 times ULNR
· Creatinine concentration > 1.5 times ULNR
· Participation in a study with an investigational product other than immunoglobulin within 3 months prior to enrollment
· Evidence of uncooperative attitude
· Any condition that is likely to interfere with evaluation of the study drug or satisfactory conduct of the trial
· Patients who are employees at the investigational site, relatives or spouse of the investigator

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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