Detail of the clinical trial
| Title of the trial | A Three-part Study of Eltrombopag in Thrombocytopenic Subjects with Myelodysplastic Syndromes or Acute Myeloid Leukemia (Part 1: open-label, part 2: randomized, double-blind, part 3: extension). ASPIRE: A study of Eltormbopag In Myelodysplastic Syndromes and Acute Myeloid Leukemia. |
|---|---|
| EudraCT number | 2011-000114-19 |
| Protocol number | TRC114968 |
| Sponsor | GlaxoSmithKline Research and Development Ltd., Global Regulatory Affairs, 1-3 Iron Bridge Road, Uxbridge, Middlesex, UB11 1BU UK |
| Indications | Oncology |
| Diagnosis | in Thrombocytopenic Subjects with Myelodysplastic Syndromes or Acute Myeloid Leukemia |
| Population in clinical trial |
Adults (18-65 years) Elderly ( > 65 years) Male Female Patients |
| Year of receiving the request to Institute (SÚKL) | 2011 |
| Date of approval by Institute (SÚKL) | 29.12.2011 |
| Date of approval by EC | 16.11.2011 |
| Date of initiation CT in ČR | 18.9.2012 |
| Date of ending CT in ČR | 29.1.2015 |
| Notice | |
| Sites |
Interní hemtolog. klinika Královské vinohrady Praha 10 ÚHKT, U Nemocnice 1 Praha 128 20 FN Brno, IHOK, Jihlavská 25 625 00 |
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