Gammaplex 10 (DrugBank: -)
1 diseaseID | Disease name (Link within this page) | Number of trials |
---|---|---|
65 | Primary immunodeficiency | 3 |
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 |
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1 | EUCTR2013-002290-21-HU (EUCTR) | 13/10/2014 | 14/07/2014 | Study to compare the blood levels and safety 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 - Study to compare Gammaplex 10% & 5% in Primary Immunodeficiency | Primary immunodeficiency diseases MedDRA version: 17.0;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Gammaplex Product Name: Gammaplex INN or Proposed INN: Human Normal Immunoglobulin Product Name: Gammaplex 10 INN or Proposed INN: Human Normal Immunoglobulin | Bio Products Laboratory Limited | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 3 | United States;Hungary;United Kingdom | ||
2 | EUCTR2013-002290-21-GB (EUCTR) | 30/04/2014 | 21/10/2013 | Study to compare the blood levels and safety 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 - Study to compare Gammaplex 10% & 5% in Primary Immunodeficiency | Primary immunodeficiency diseases MedDRA version: 17.1;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Gammaplex Product Name: Gammaplex INN or Proposed INN: Human Normal Immunoglobulin Product Name: Gammaplex 10 INN or Proposed INN: Human Normal Immunoglobulin | Bio Products Laboratory Limited | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 3 | United States;Hungary;Israel;United Kingdom | ||
3 | 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 |