Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (NCT00542997) | Clinical Trial Compass
CompletedPhase 3
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy
France, Germany51 participantsStarted 2007-09
Plain-language summary
The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).
Who can participate
Age range2 Years – 65 Years
SexALL
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Inclusion Criteria:
* Subjects with primary humoral immunodeficiency, namely with a diagnosis of Common Variable Immunodeficiency (CVID) as defined by the Pan-American Group for Immunodeficiency (PAGID) and European Society for Immunodeficiencies (ESID), X-linked agammaglobulinemia (XLA) as defined by PAGID and ESID, or Autosomal Recessive Agammaglobulinemia
* Chest X-ray or CT scan obtained within 1 year prior to enrolment
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
* Allergic or other severe reactions to immunoglobulins or other blood products associated with high anti-IgA
Additional criteria may apply and examination by an investigator is required to determine eligibility.
What they're measuring
1
Total Serum IgG Trough Levels
Timeframe: Up to 6 months prior to first IgPro20 treatment (Pre-study treatment) and Week 12 to 17 (IgPro20 treatment)