Gammaplex (5%) (DrugBank: -)
1 diseaseID | Disease name (Link within this page) | Number of trials |
---|---|---|
65 | Primary immunodeficiency | 1 |
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | NCT01963143 (ClinicalTrials.gov) | February 2014 | 13/9/2013 | Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases | 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 | Primary Immune Deficiency Disorders;Common Variable Immunodeficiency;X-linked Agammaglobulinaemia;Hyper-IgM Syndrome | Biological: Gammaplex (5%);Biological: Gammaplex 10 | Bio Products Laboratory | NULL | Completed | 2 Years | 55 Years | All | 48 | Phase 3 | United States;Hungary;United Kingdom |