Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID) (NCT01581593) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)
United States45 participantsStarted 2012-11-12
Plain-language summary
The purpose of this study is to determine whether Kedrion IVIG 10% (an immunoglobulin solution) is effective in treating Primary Immunodeficiency (PID).
Who can participate
Age range2 Years – 70 Years
SexALL
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Inclusion Criteria:
* Confirmed clinical diagnosis of a Primary Immunodeficiency Disease
* Male or female, ages 2 to 70 years
* Received 300-900 mg/kg of a licensed IVIG therapy at 21 or 28 day intervals for at least 3 months prior to this study
* 2 documented IgG trough levels of ≥ 5 g/L are obtained at two infusion cycles (21 or 28 days) within 12 months (one must be within 6 months) prior to study enrolment
* Non-pregnant females of child-bearing potential who agree to use adequate birth control during the study
* Subject is willing to comply with the protocol
* Authorization to access personal health information.
* Signed the informed consent form and a child assent form, if appropriate.
* If currently participating in a clinical trial with another experimental IVIG may be enrolled if they have received stable IVIG therapy for at least 3 infusion cycles prior to receiving Kedrion IVIG 10% and all inclusion and exclusion criteria are satisfied
* If currently participating in a trial of SCIG can be enrolled if they are switched to IVIG for three infusion cycles (21 or 28 days) prior to enrolment in this study
Exclusion Criteria:
* Has secondary immunodeficiency.
* Newly diagnosed and has not been treated with immunoglobulin or has been diagnosed with dysgammaglobulinemia or isolated IgG subclass deficiency.
* Has a history of repeated reactions or hypersensitivity to IVIG or other injectable forms of IgG.
* Has a history of thrombotic events defined by at least 1 event i…
What they're measuring
1
Incidence of Acute, Serious Bacterial Infections in the Total ITT Population.