Open-label study of S888711 in adults with persistent or chronic ITP

• Research type

  Research Study

• Full title

  An open-label safety study of S-888711 in adult subjects with relapsed persistent or chronic immune thrombocytopenia with or without prior splenectomy

• IRAS ID

  49823

• Contact name

  Adrian Newland

• Sponsor organisation

  Shionogi USA, Inc.

• Eudract number

  2009-017942-30

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Open-label safety study of S-888711 in adult participants with relapsed persistent or chronic immune thrombocytopenia (ITP). This study is being conducted to assess the long term safety of S-88871 (study drug) in the treatment of patients who have been diagnosed with persistant or chronic ITP (low platelet counts). Platelets circulate in the blood and are involved in a complex process which causes bleeding to stop (haemostasis). If the number of platelets is too low, this process is disturbed and excessive bleeding may occur. The study drug stimulates platelet production with oral administration and based on other clinical trials conducted, it has been well tolerated. The frequency of adverse events (AE) was low and most AEs were mild in severity. Seven countries worldwide are participating in this study including the UK. Approximately 60 patients with relapsed persistent or chronic ITP with or without splenectomy are planned to participate in this study. Only patients who have participated in the Phase II study 0913M0621 and have either completed their treatment or discontinued treatment due to a platelet count > 400,000/æL will be enrolled on this study. The study is planned to continue until the study drug is commercially available or the sponsor decides to discontinue the study. In the UK, the study will be conducted by specialist haematologists at NHS hospitals in England. This is an open-label study. The participants will begin dosing with the study drug at a dose of 0.50 mg. The dose will be adjusted accordingly in order to achieve and maintain a therapeutic response on the platelet count. At the end of the dosing adjustment period, participants that have a platelet count between 50,000/æL to 400,000/æL will then enter the long-term maintenance phase. A series of tests and assessments including general health and research related blood and urine tests, physical examinations, ECG will be performed in order to assess the participants?? safety and the effectiveness of the study drug.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  10/H0907/20

• Date of REC Opinion

  7 Jun 2010

• REC opinion

  Further Information Favourable Opinion