Calendario›JAZZ›European VOD Registry
European VOD Registry
Ensayo de Jazz Pharmaceuticals plc en Hepatic Veno-Occlusive Disease (del registro, en inglés).
- Fase
- no aplica
- Estado
- Completado
- Participantes
- 176
- Centros
- 53
- Fin del objetivo primario
- jul 2019
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio observacional. Comenzó en abr 2015.
Qué mide
Incidence rate of specific SAE of interest (over 12 months) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroFollowing the licencing of a new drug, Defitelio®, indicated for the treatment of severe Veno-Occlusive Disease of the liver (sVOD), a rare but serious complication of haematopoietic stem cell transplantation (HSCT), as a specific obligation (SOB), the manufacture and marketing Authorisation Holder (MHA) (Gentium, a Jazz Pharmaceuticals Company) was required by PRAC (Pharmacovigilance Risk Assessment Committee) to set up a disease registry to collect safety and outcome data, and to assess patterns of utilization of Defitelio® in the post-approval setting. This registry is a Post Authorization Safety Study (PASS), is being coordinated in collaboration with the European Society for Blood and Marrow Transplantation (EBMT). For this study, anonymised clinical data are being collected from patients who develop VOD and and treated with and patients who have been treated with Defitelio® for conditions other than sVOD. The study DOES NOT involve decisions about treatment, which are clinical decisions, but merely collection of data for patients who develop this complication, whether or not they receive treatment and for patients who are treated with Defitelio® for any other reasons.The study DOES NOT involve decisions about treatment, which are clinical decisions, but merely collection of data for patients who develop this complication, whether or not they receive treatment and for patients who are treated with Defitelio® for any other reasons.
Más ensayos de JAZZ
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Epidiolex · OPERA | no aplica | En marcha, sin reclutar | jul 2026 (prevista, ya pasada: sin actualizar en el registro) |
| ONC206 | Fase 1 | Reclutando pacientes | jul 2026 (prevista, ya pasada: sin actualizar en el registro) |
| JZP047 | Fase 1 | Reclutando pacientes | jul 2026 (prevista, ya pasada: sin actualizar en el registro) |
| Zanidatamab · HERIZON-GEA-01 | Fase 3 | En marcha, sin reclutar | jul 2026 (real) |
| Zanidatamab | Fase 2 | Reclutando pacientes | dic 2026 (prevista) |
| Epidiolex 100 mg · EpiTALY | no aplica | En marcha, sin reclutar | feb 2027 (prevista) |
Todos los de JAZZ, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT03032016), actualizada en oct 2019.