Condition: Immune Thrombocytopenia (ITP) · ITP - Immune Thrombocytopenia · ITP · Sponsor: argenx
The main purpose of this study is to confirm the correct dose of efgartigimod IV for treating patients aged 12 to younger than 18 years with chronic immune thrombocytopenia (ITP). The study consists of a double-blinded treatment period (DBTP) in which the participants will be randomized in a 2:1 ratio to receive either efgartigimod IV or placebo IV. At the end of the treatment period (up to 24 weeks), all participants will receive efgartigimod IV during the first year open-label treatment period (OLTP1). At the end of the first OLTP1, participants may begin a second year (OLTP2). After the OLTP2, the participants will enter a follow-up period (approximately 8 weeks) while off study drug. The participants will be in the study for up to 138 weeks. More information can be found here: https://clinicaltrials.argenx.com/advancejunior
This description comes directly from the study's public registry record.
Sabine Coppieters, MD · 857-350-4834 · clinicaltrials@argenx.com
Always discuss trial participation with your own doctor first.
| Centre Hospitalier Universitaire de Bordeaux Groupe Hospitalier Pellegrin Hopital des Enfants | Bordeaux, France | Recruiting |
| Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK) | Berlin, Germany | Recruiting |
| Gaslini Children's Hospital | Genoa, Italy | Recruiting |
| Fondazione IRCCS San Gerardo dei Tintori | Monza, Italy | Recruiting |
| Bambino Gesu Children's Hospital | Roma, Italy | Recruiting |
| A.O.U. Citta della Salute e della Scienza di Torino - Ospedale Infantile Regina Margherita | Torino, Italy | Recruiting |
| Vilnius University Hospital Santaros Klinikos, Children's Hospital | Vilnius, Lithuania | Recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny nr 4 | Lodz, Poland | Recruiting |
| Uniwersytecki Szpital Dzieciecy w Lublinie | Lublin, Poland | Recruiting |
| Institutul Clinic Fundeni | Bucharest, Romania | Recruiting |
| Institute Of Mother And Child Healthcare Of Serbia Dr Vukan Cupic | Belgrade, Serbia | Recruiting |
| University Clinical Centre of Kragujevac | Kragujevac, Serbia | Recruiting |
+ 8 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07194850