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Clinical trial

A Phase III, Multicenter, Open-label, Randomized, Two-Period, Crossover Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases

NCT01963143 is registered in ClinicalTrials.gov with Bio Products Laboratory as lead sponsor.

NCT NCT01963143
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase III, Multicenter, Open-label, Randomized, Two-Period, Crossover Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases
Lead sponsor
Bio Products Laboratory
Phase
Phase 3
Overall status
Completed
Start date
February 28, 2014
Completion date
May 31, 2016
Enrollment
48 (actual)
Sites
17

Conditions

As the registry lists them; a condition with its own page is linked.

common variable immunodeficiency, hyper-igm syndrome, primary immune deficiency disorders, x-linked agammaglobulinaemia