Platelet response & remission in adults with ITP receiving romiplostim

• Research type

  Research Study

• Full title

  A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim

• IRAS ID

  56090

• Contact name

  Roberto Stasi

• Sponsor organisation

  Amgen Inc

• Eudract number

  2010-019987-35

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Immune Thrombocytopenic Purpura (ITP) is an autoimmune disorder characterised by a low number of platelet cells in the blood (thrombocytopenia). Patients with ITP are at risk of bruising, bleeding and more seriously brain haemorrhage. In Europe, the incidence of ITP in adults is estimated at 20,863 new cases per year. Few drug therapies have received regulatory approval for the treatment of ITP and many commonly used ITP treatments cannot be given to patients over a long period of time due to associated side effects. Removal of the spleen (splenectomy) is a possible treatment for ITP but is undesired as there can be complications associated with this surgery.The purpose of this study is to determine if treatment with the investigational product romiplostim over a 12 month period will raise platelet counts in adults, who have been diagnosed with ITP within 6 months of beginning this study, allowing their ITP disorder to resolve (ITP remission) without requiring the removal of the patient??s spleen. Patients who do not achieve ITP remission during the 12 month treatment period will then go through a romiplostim dose reduction period or a stabilisation period dependent upon each patient??s response and dose to treatment.Patients will be recruited and treated at 3 NHS hospitals in England. All recruited patients will receive romiplostim for an expected average of 15 months depending on their platelet response to the treatment.

• REC name

  London - South East Research Ethics Committee

• REC reference

  10/H1102/51

• Date of REC Opinion

  29 Oct 2010

• REC opinion

  Further Information Favourable Opinion