Gammaplex (5%) ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
65Primary immunodeficiency1

65. Primary immunodeficiency


Clinical trials : 500 Drugs : 614 - (DrugBank : 119) / Drug target genes : 92 - Drug target pathways : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1NCT01963143
(ClinicalTrials.gov)
February 201413/9/2013Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency DiseasesA 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 DiseasesPrimary Immune Deficiency Disorders;Common Variable Immunodeficiency;X-linked Agammaglobulinaemia;Hyper-IgM SyndromeBiological: Gammaplex (5%);Biological: Gammaplex 10Bio Products LaboratoryNULLCompleted2 Years55 YearsAll48Phase 3United States;Hungary;United Kingdom