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

Completed · Phase 3

Conditions studied: Primary Immune Deficiency

In brief

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

Key facts

Study ID

NCT00419341

Run by

CSL Behring

People needed

49

Starts

2006-11-01

Expected to finish

2008-10-01

Last updated by the study team

2013-01-25

Who can join

Age: 2 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study Site — Los Angeles, California, United States
• Study Site — Los Angeles, California, United States
• Study Site — Centennial, Colorado, United States
• Study Site — North Palm Beach, Florida, United States
• Study Site — Atlanta, Georgia, United States
• Study Site — Fort Wayne, Indiana, United States
• Study Site — Indianapolis, Indiana, United States
• Study Site — Iowa City, Iowa, United States
• Study Site — St Louis, Missouri, United States
• Study Site — Newark, New Jersey, United States
• Study Site — New York, New York, United States
• Study Site — Philadelphia, Pennsylvania, United States
• Study Site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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