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Само по покана Фаза 2/3 NCT05374590

Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis

Фаза 2/3 – комбинирано изпитване
Заболявания: Generalized Myasthenia Gravis gMG

Спонсор: argenx

Налично на: БГ
Обобщение
The purpose of this trial is to evaluate the long-term safety of efgartigimod IV and efgartigimod PH20 SC administered to participants with gMG in the antecedent studies, ARGX-113-2006 and ARGX-113-2207, respectively. Participants will receive efgartigimod IV or efgartigimod PH20 SC, using the dose administered in the antecedent studies. Participants who have not reached the age of 18 can remain in the study until efgartigimod becomes commercially available in the respective country or available through another continued access program for gMG. Participants who have reached the age of 18 can remain in the study for a maximum of 2 years, until efgartigimod becomes commercially available in the respective country or available through another continued access program for gMG, whichever comes first.
Кой може да участва
Inclusion Criteria: * The participant completed ARGX-113-2006, defined as: 1. The participant reached End of Trial in trial ARGX-113-2006 or End of Study in ARGX-113-2207 and agreed to participate in the ARGX-113-2008 trial. 2. The participant qualifies for retreatment in trial ARGX-113-2006, but cannot complete a Treatment Period (TP) and the required Intertreatment Period (IP) visits within the ARGX-113-2006 trial's timeframe. * Either the participant or the participant's legally authorized representative can understand the requirements of the trial and provide written informed consent/assent, and willingness and ability to comply with the trial protocol procedures. * Contraceptive use for sexually active participants should be consistent with local regulations for those participating in clinical studies. Exclusion Criteria: * Female adolescents of childbearing potential (FAOCBP): Pregnancy or lactation, or the participant intends to become pregnant during their participation in the study. * Discontinued early from ARGX-113-2006 or ARGX-113-2207 treatment. * Clinically significant uncontrolled chronic bacterial, viral, or fungal infection at study entry not sufficiently resolved in the investigator's opinion or known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of gMG or put the participant at undue risk.
Интервенции
Efgartigimod IV or Efgartigimod PH20 SC
BIOLOGICAL
Места на провеждане 16
Белгия (2)
Universitair Ziekenhuis Antwerpen
Edegem
UZ Gent
Ghent
Канада (1)
Childrens Hospital of Eastern Ontario
Ottawa
Франция (1)
AP-HM- Hôpital de La Timone
Marseille
Германия (1)
Universitätsklinikum Essen
Essen
Израел (1)
Hadassah Medical Center- Ein Kerem
Jerusalem
Нидерландия (1)
Leids Universitair Medisch Centrum
Leiden
Полша (3)
Uniwersyteckie Centrum Kliniczne w Gdansku
Gdansk
Wielospecjalistyczna Poradnia Lekarska Synapsis
Katowice
Centralny Szpital Kliniczny - Uniwersyteckie Centrum Kliniczne WUM
Warsaw
Испания (1)
Hospital Universitari i Politecnic La Fe de Valencia
Valencia
Великобритания (2)
Great Ormand Street Hospital for Children NHS Foundation Trust - Great Ormond Street Hospital - Pediatric Neurology
London
Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital Children's Hospital
Oxford
САЩ (3)
Atrium Health Neurology Specialty Care
Charlotte , North Carolina
University of Virginia (UVA) Health - Developmental Pediatrics Clinic
Charlottesville , Virginia
Ann and Robert H Lurie Children's Hospital of Chicago - Main Hospital
Chicago , Illinois
Технически детайли
Статус
Само по покана
Фаза
Фаза 2/3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
2 Years
Максимална възраст
18 Years
Здрави доброволци
Не
Начална дата
18.08.2022
Крайна дата
01.09.2029
Регистрационен номер
NCT05374590
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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