Phase 2 study of S-888711 for patients with persistent or chronic ITP

• Research type

  Research Study

• Full title

  A multicenter, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and safety of S-888711 tablets administered once-daily for 42 days to adult subjects with relapsed persistent or chronic immune thrombocytopenia with or without prior splenectomy.

• IRAS ID

  44142

• Contact name

  Adrian Newland

• Sponsor organisation

  Shionogi USA, Inc.

• Eudract number

  2009-016950-42

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Phase 2, randomised, double-blind study to investigate the efficacy and safety of S-888711 to participants with relapsed persistent or chronic immune thrombocytopenia (ITP). This study is being conducted to assess the effect of S-88871 (study drug) on the platelet count of patients who have been diagnosed with chronic or persistent ITP (low platelet count). 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. In ITP the body forms antibodies against the own platelets and destroys them. In Persistent ITP the disease lasts between 3 to 12 months from diagnosis or patients do not reach spontaneous remission or do not maintain complete response off therapy. In chronic ITP the disease lasts for more than 12 months. The orally administered study drug stimulates platelet production. Based on other clinical trials conducted, the study drug has been well tolerated with most of the adverse events having been 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 that is estimated to last approximately 2 to 3.5 months. In the UK, the study will be conducted by specialist haematologists at NHS hospitals in England. This is a placebo-controlled, dose-ranging study. The participants will be assigned by chance to one of the four treatment groups (0.5 mg, 0.75 mg or 1.0 mg of study drug or placebo - dummy drug). Neither the study doctor nor the participant will be able to choose or will know which treatment the participant's on. The treatment period will last approximately 6 weeks. Study drug will be administered to all subjects under site staff supervision at Visit 1 and on all other days will be self-administered once daily with 240ml of water. At the end of the treatment period or if the treatment period is terminated early, the participant may be able to continue on an extension study. Participants that do not enter the extension study will have weekly Follow Up. 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/H0907/19

• Date of REC Opinion

  7 Jun 2010

• REC opinion

  Further Information Favourable Opinion