GROUP TRIAL OF IGIV IN PATIENTS WITH PID

$0M01FY2000RRNIH

Yeshiva University, New York NY

Investigators

Linked publications & trials

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Abstract

This is a Phase II randomized blind, parallel group, multicenter, therapeutic equivalence trial. The Primary Immune Deficiency (PID) patients will be randomly assigned to one of the two treatment groups: experimental IGIV (IGIV-C, 10%) or control IGIV (IGIV-S/D, 10%). A total of 152 patients will be enrolled with a confirmed diagnosis of Primary Immune Deficiency and who are on stable IVUG replacement therapy for at least three months prior to entry into the trial. Nine infusions, with one of the study drugs, will be every three to four weeks for nine months. Patients will remain on the fixed individual replacement dose and dose interval established prior to entry into the study.

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