Primary Immune Deficiency

Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy

NCT00419341 | PHASE 3 | INTERVENTIONAL

The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).

13 Sites

49 Participants

Recruiting

2 Years to 75 Years

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Study Site

Los Angeles,California,United States,90025

Study Site

Los Angeles,California,United States,90027

Study Site

Centennial,Colorado,United States,80112

Study Site

North Palm Beach,Florida,United States,33408

Study Site

Atlanta,Georgia,United States,30322

Study Site

Fort Wayne,Indiana,United States,46815

Study Site

Indianapolis,Indiana,United States,46202

Study Site

Iowa City,Iowa,United States,52242

Study Site

St.Louis,Missouri,United States,63104

Study Site

Newark,New Jersey,United States,07103

Study Site

New York,New York,United States,10029

Study Site

Philadelphia,Pennsylvania,United States,19104

Study Site

Dallas,Texas,United States,75230

Study Eligibility Criteria

Inclusion Criteria

* Male or female aged 2 to 75 years
* Subjects with primary humoral immunodeficiency, namely with a diagnosis of: CVID (Common Variable Immunodeficiency) as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies) or XLA (X-linked Agammaglobulinemia)
* Written informed consent

Exclusion Criteria

* Newly diagnosed PID
* Evidence of an active serious infection at the time of screening (i.e., but not limited to: bacteremia/septicemia, pneumonia, fungal osteomyelitis)
* 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
* Allergic reactions to immunoglobulins or other blood products
* Known antibodies to Immunoglobulin A (IgA)
* The subject is receiving steroids (oral and parenteral, daily ≥ 0.15 mg of prednisone equivalent/kg/day) or other systemic immunosuppressants
* Female who is pregnant, breast feeding or planning a pregnancy during the course of the study
* Participation in a study with an investigational product other than (IVIG) within 1 month prior to enrollment
* A positive result at screening on any of the following viral markers: Human Immunodeficiency Virus (HIV), Hepatitis C virus (HCV) and Hepatitis B virus (HBV)
* Aspartate aminotransferase (ASAT) or Alanine aminotransferase (ALAT) concentration \> 2.5 times the upper normal limit (UNL)
* Creatinine concentration \> 1.5 times the UNL
* Any condition that is likely to interfere with evaluation of the study drug or satisfactory conduct of the trial

Additional Studies

Additional studies can be found at ClinicalTrials.gov