2025-12-01
minor
Study Status, Oversight, Contacts/Locations v23
Study sitesdetails revised at 2 of 24 sites
2025-07-16
minor
Study Identification, Study Status, Contacts/Locations v22
Study sitesdetails revised at 5 of 24 sites
Study titlerevised
Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children withWith Generalized Myasthenia Gravis
2024-10-28
minor
Study Identification, Study Status, Oversight, Contacts/Locations v21
Primary completion date2024-08→2027-03
Completion date2024-08→2027-03
Study sitescontacts updated at 6 of 24 sites
Study titlerevised
Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children Withwith Generalized Myasthenia Gravis
Show 19 earlier versions
2024-04-10
minor
Study Status, Contacts/Locations v19
Primary completion date2024-03→2024-08
Completion date2024-03→2024-08
Study sites23→24
2024-03-13
minor
Study Status, Contacts/Locations v18
2024-01-15
minor
Study Status, Contacts/Locations v17
Study sites22 entries, revised
InvestigatorAnn Siteand Robert H Lurie Childrens Hospital of Chicago
University of North Carolina at Chapel Hill
University of Virginia
Medizinische Universitat Wien
UZ Antwerpen
Hopitaux de La Timone
Groupe Hospitalier Necker Enfants Malades
JSC Evex Hospitals
LEPL ''Tblisi State Medical University Givi Zhvani
Charité - US0010120Universitätsmedizin Berlin
InvestigatorUniversitätsklinikum SiteEssen
Azienda Ospedaliero Universitaria A Meyer - US0010003
Investigator siteINCIPIT - US0010142PIN
InvestigatorIstituto SiteG Gaslini Ospedale Pediatrico IRCCS - AT0430010
Investigator SiteINCIPIT - BE03 [...] [...]
2024-01-09
minor
Study Status, Contacts/Locations v16
Study sitesdetails revised at 2 of 22 sites
2023-10-02
minor
Study Status, Contacts/Locations v15
2023-08-16
minor
Study Status, Eligibility v14
Eligibility criteria-389 characters
[...] erase (AChE) inhibitors and should be on stable concomitant Generalized Myasthenia Gravis (gMG) therapy of adequate duration before screening.
Positive ser [...] ants: Male participants must agree to not donate sperm from theof time theproviding informed consent form was signed/assent until thethey endhave ofcompleted the trial.
Female participants: Female adolescents of child [...] can be administered.
Exclusion Criteria:
Participants with Myasthenia Gravis Foundation of America (MGFA) class I, IVb, and V.
Female adolescents of childbearing potential (FAOCBP): Pregnancy or lactation, or the participant in [...] [...]
2023-07-28
minor
Study Status, Contacts/Locations v13
Study sitesdetails revised at 1 of 20 sites
2023-06-13
minor
Study Status, Contacts/Locations v12
2023-05-02
minor
Study Status, Contacts/Locations v11
2023-01-13
minor
Study Status, Contacts/Locations v10
Primary completion date2022-12-31→2024-03
Completion date2023-03-30→2024-03
Study sites16→17
2022-11-02
minor
Study Status, Contacts/Locations v9
2022-09-26
minor
Study Status, Contacts/Locations v8
2022-08-31
minor
Study Status, Contacts/Locations v7
2022-07-19
minor
Study Status, Contacts/Locations v6
2022-06-28
minor
Study Status, Contacts/Locations v5
2022-04-19
minor
Study Status, Contacts/Locations v4
2022-02-03
minor
Study Status, Contacts/Locations v3
2021-11-26
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-07-30→confirmed 2021-10-26
Study sites0→3
2021-06-04
minor
Study Status, Study Description, Outcome Measures, Eligibility v1
Primary completion date2024-10-31→2022-12-31
Completion date2025-04-30→2023-03-30
Start date2021-05-30→2021-07-30
Eligibility criteria+293 characters
[...] f contraception for those participating in clinical trials.
A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
Male participants: Male participants must agree to not donat [...] severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening.
Using the following prior or concomitant therapies:
Use of [...] (PLEX) within 4 weeks before screening.
Total immunoglobulin G (IgG) levels <6 g/L below the lower limit of normal (LLN) according to the reference ranges of the central laboratory for participa [...] [...]
Secondary endpoints19 entries, revised
Incidence and severity of adverse events (AEs) and, serious adverse events (SAEs) and adverse events of special interest (AESIs)
ValuesAbsolute values of total Myasthenia Gravis Activity of Daily Living (MG-ADL [...] to 24, with higher total scores indicating more impairment.
ValueAbsolute values of total Quantitative Myasthenia Gravis Score (QMG score). [...] where higher total scores indicate more severe impairments.
ValuesAbsolute values of total score EuroQoL 5 Dimensions Youth (EQ-5D-Y)