E5501-G000-305 - E5501 Chronic Immune Thrombocytopenia

• Research type

  Research Study

• Full title

  A Phase 3, Multicentre, Randomized, Double-blind, Active-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus Eltrombopag, in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)

• IRAS ID

  98087

• Contact name

  Nichola Cooper

• Sponsor organisation

  Eisai Limited

• Eudract number

  2011-000831-10

• Clinicaltrials.gov Identifier

  NCT01433978

• Research summary

  The main purpose of this research study is to find out whether the study drug E5501 is safe and effective in increasing and then maintaining the level of platelets in patients with chronic immune thrombocytopenia (cITP), compared to a drug call eltrombopag, which is also known as Revolade©. The study is split into three parts; the Screening Period, which will last for up to 28 days; the Core Study, which will last for up to 34 weeks, and the Extension Phase, which will last for up to just over 112 weeks. Participants can participate in all three parts, or just the Screening Period and Core Study. During the core study phase participants will be randomly assigned to one of two treatment groups to receive either: ?½ E5501 20 mg plus eltrombopag placebo, or ?½ Eltrombopag 50mg plus E5501 placebo Subjects will be allowed to have their dose increased or decreased depending on the results of the participant's platelet counts. Subjects who do not continue into the Extension Phase will have their study drug dose decreased until the study drug is discontinued. During the extension phase all participants will take E5501. The dose of E5501 in the extension phase will depend on the participant's dose in the core phase. The E5501 dose may be increased or decreased during the extension phase depending on the results of the participant's platelet counts. All subjects who have either completed the Extension Phase of the study or discontinue early from any phase will have the amount of study medication they are taking reduced by one dose level until they are no longer taking any study medication. The clinical trial will be conducted in approximately 80 clinics in Europe, North America Asia Pacific and Russia, and will include up to 286 patients in total who will be given study medication.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  12/EE/0165

• Date of REC Opinion

  2 Jul 2012

• REC opinion

  Further Information Favourable Opinion