Essential Thrombocythemia (ET) Clinical Trial
Official title:
Multicentre Paediatric Disease Registry in Essential Thrombocythaemia
| NCT number | NCT01198717 |
| Other study ID # | SPD422-404 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | September 28, 2010 |
| Est. completion date | March 1, 2016 |
| Verified date | March 2021 |
| Source | Takeda |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The aim of this study is to evaluate the progression of ET in children (aged 6-17years inclusive) over a period of 5 years maximum. The study will also assess how children are diagnosed, treatment options for those children with symptoms and events related to their ET and the outcomes of those treatments.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | March 1, 2016 |
| Est. primary completion date | March 1, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Years to 17 Years |
| Eligibility | Inclusion Criteria: - 6 years or over and less than 18 years patient has ET according to the WHO criteria as guidance Exclusion Criteria: - Interventional clinical study participation |
| Country | Name | City | State |
|---|---|---|---|
| Czechia | Paediatric Clinic University Hospital Olomouc | Olomouc | |
| Czechia | Clinic of Paediatric haematology and oncology University Hospital Motol | Prague | |
| France | Paediatric Oncology Unit, Hopital Cote De Nacre | Caen | |
| France | Practicen Hospitalier , Institute d'Hematologie et Oncologie Pediatrique | Lyon | |
| France | Centre Hospitalier Lyon Sud - service Hématologie | Pierre Benite | |
| France | Hopitaux de Brabois | Vandoeuvre Les Nancy | |
| Germany | Klinikum Chemnitz GmbH, Klinik für Kinder-und Jugendmedizin | Chemnitz | |
| Germany | Zentrum für Kinder- und Jugendmedizin Klinik II / III | Frankfurt | |
| Greece | "Agia Sophia" Children's Hospital | Athens | |
| Italy | Dipartimento di Biomedicina dell'Eta Evolutiva. University of Bari | Bari | |
| Italy | Servico de Oncoematologia Peditrica | Cagliari | |
| Italy | UO Oncoematologia AOU Meyer | Florence | |
| Italy | Pediatric Hamatology Unit. Department of Hematology and Oncology. G Gaslini Children's hospital. Largo | Genova | |
| Italy | Chairmen of Pediatric Hamatooncology Outpatient Clinic. Hospital San Gerardo | Monza | |
| Italy | Department of Oncology, Pausilipon Hospital, AORN Santobono | Napoli | |
| Italy | Azienda Ospedaliera di Padova | Padova | |
| Italy | Department of Cellular Biotechnologies and Hematology. Sapienza University | Rome | |
| Italy | Ospedale Casa Sollievo della Sofferenza | San Giovanni | |
| Italy | Hamatology Unit. Paediatric Department. University of Torino | Torino | |
| Spain | Hospital Universitario Mutua de Terrassa | Barcelona | |
| Spain | Jefe de Servicio Oncología Y Hematología Pediátricas | Barcelona | |
| Spain | Sección de Hematología Pediátrica. Hospital de la Santa Creu i Sant Pau | Barcelona | |
| Spain | Servicio de Hematología Clínica, Hospital Sant Joan de Déu Barcelona | Barcelona | |
| Spain | Department Haematology, Hospital Ramon y Caja | Madrid | |
| Spain | Servicio de Transfusión, Hospital Universitario Niño Jesús | Madrid | |
| Spain | Hospital Universitario Virgen de la Arrixac | Murcia | |
| Spain | Complexo Hospitalario Universitario, Santiago | Santiago de Compostela | |
| Switzerland | Leitender Arzt, Pädiatrische Hämatologie/Onkologie Kinderspital | Luzern | |
| United Kingdom | St James University Hospital | Leeds | |
| United Kingdom | Royal Manchester Childrens Hospital, | Manchester | |
| United Kingdom | Children's Clinic, Royal Berkshire Hospital | Reading | |
| United Kingdom | Sheffield Childrens Hospital | Sheffield |
| Lead Sponsor | Collaborator |
|---|---|
| Shire |
Czechia, France, Germany, Greece, Italy, Spain, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Treatment effects on platelet count in children ages 6-17 years inclusive. | 60 months | ||
| Secondary | Drug utilization of cytoreductive therapy in children ages 6-17 years inclusive | 60 months |
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