Safety of Long Term Dosing of Romiplostim in MDS subjects

• Research type

  Research Study

• Full title

  An Open Label Extension Study Evaluating the Safety of Long Term Dosing of Romiplostim in Thrombocytopenic Subjects with Myelodysplastic Syndromes (MDS)

• IRAS ID

  56428

• Contact name

  David Bowen

• Sponsor organisation

  Amgen Ltd

• Eudract number

  2007-001516-24

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The purpose of this study is to provide information on the long term use of romiplostim in thrombocytopenic patientssubjects with MDS.patients will be asked to participate because they have low platelet counts and MDS and because they have participated in another study of romiplostim in patients with MDS.patients will visit the hospital to receive either weekly or every other week doses of romiplostim.During these protocol visits, the study doctor in the study will take blood, examine the patient, and ask questions about how they are feeling.The study doctor will provide this information to Amgen, the sponsor of the study, in order to show the effects of long term use of romiplostim.This study will take place in up to approximately 250 centres in the US, Europe, Australia and Canada. Approximately 250 patients will participate in this study. In the UK, the maximum number of centres will be 9 and the expected number of UK patients will be 12.The study will remain open for the treatment of patientssubjects until December 2011.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  10/H1306/62

• Date of REC Opinion

  20 Oct 2010

• REC opinion

  Further Information Favourable Opinion