Spots Global Cancer Trial Database for Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis
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Trial Identification
Brief Title: Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis
Official Title: Open-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis
Study ID: NCT04833894
Conditions
Interventions
Study Description
Brief Summary: The purpose of this trial is to investigate the PK, PD, safety, and activity of efgartigimod IV in children and adolescents aged from 2 to less than 18 years of age with gMG. Trial details include: * The maximum trial duration for each individual participant will be approximately 28 weeks * The treatment duration will be 8 weeks for the dose-confirmatory part (Part A) and 18 weeks for the treatment response-confirmatory part (Part B)
Detailed Description:
Keywords
Eligibility
Minimum Age: 2 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ann and Robert H Lurie Childrens Hospital of Chicago, Chicago, Illinois, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
University of Virginia, Charlottesville, Virginia, United States
Medizinische Universitat Wien, Wien, , Austria
UZ Antwerpen, Antwerpen, , Belgium
British Columbia Children's Hospital, Vancouver, , Canada
Hopitaux de La Timone, Marseille, , France
Groupe Hospitalier Necker Enfants Malades, Paris, , France
JSC Evex Hospitals, Tbilisi, , Georgia
LEPL ''Tblisi State Medical University Givi Zhvani, Tbilisi, , Georgia
Charité - Universitätsmedizin Berlin, Berlin, , Germany
Universitätsklinikum Essen, Essen, , Germany
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari, Bari, , Italy
Azienda Ospedaliero Universitaria A. Meyer, Florence, , Italy
Istituto G Gaslini Ospedale Pediatrico IRCCS, Genova, , Italy
Leiden University Medical Center, Leiden, , Netherlands
Uniwersyteckie Centrum Kliniczne, Gdańsk, Woj. Pomorskie, Poland
Wielospecjalistyczna Poradnia Lekarska Synapsis, Katowice, Woj. Slaskie, Poland
Uniwersyteckie Centrum Kliniczne WUM, Centralny Szpital Kliniczny, Warszawa, , Poland
Hospital Sant Joan de Deu, Barcelona, Cataluña, Spain
Hospital Universitari i Politecnic La Fe de Valencia, Valencia, , Spain
Great Ormond Street Hospital for Children, London, , United Kingdom
Royal Manchester Children's Hospital, Manchester, , United Kingdom
Oxford University hospitals NHS Foundation Trust-Oxford Children's Hospital, Oxford, , United Kingdom
Contact Details
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