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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 36

Inclusion Criteria

Male or female aged > 24 months and 65 years. Subjects with primary humoral immunodeficiency, namely with adiagnosis ofo CVID as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies)o or XLA as defined by PAGID and ESIDo or Autosomal Recessive Agammaglobulinemia. Subjects who have received IVIG therapy at regular 3- or 4-week intervals or SCIG therapy at regular weekly intervalsat 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 Upper Limit of Normal Range (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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