E5501-G000-310 Thrombocytopenia associated with Liver Disease

• Research type

  Research Study

• Full title

  A Randomized, Global, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Once-daily Oral Avatrombopag for the Treatment of Adults with Thrombocytopenia Associated with Liver Disease Prior to an Elective Procedure

• IRAS ID

  144059

• Contact name

  Kaushik Agarwal

• Contact email

  kosh.agarwal@kcl.ac.uk

• Sponsor organisation

  Eisai Limited

• Eudract number

  2013-000965-34

• Clinicaltrials.gov Identifier

  NCT01972529

• Research summary

  Thrombocytopenia is the reduction in the number of platelets in the blood. Platelets are involved in the process of blood clotting. This study will evaluate the study drug avatrombopag in the treatment of thrombocytopenia associated with liver disease prior to an elective procedure, to reduce the need for platelet transfusions or any rescue procedure for bleeding due to procedural and post-procedural bleeding complications. An elective procedure is a procedure, such as surgery, that has been scheduled in advance.

  It is planned that approximately 80 to 100 sites worldwide will take part.

  Subjects will be enrolled into one of two cohorts (groups) according to their current platelet count. Within each cohort subjects will be further divided into groups determined by their risk of bleeding associated with the elective procedure and hepatocellular carcinoma (HCC) status. HCC is the most common type of liver cancer.

  Within the lower platelet count group subjects will be randomly assigned in a 2:1 ratio to receive avatrombopag or placebo (inactive drug) as follows:
  Group A: 60 mg avatrombopag
  Group B: Matching placebo
  Within the higher platelet count group subjects will be randomly assigned in a 2:1 ratio to receive avatrombopag and placebo as follows:
  Group C: 40 mg avatrombopag
  Group D: Matching placebo

  Each subject will receive study drug for 5 days.

  This study is being organised by Eisai

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  14/LO/0609

• Date of REC Opinion

  3 Jul 2014

• REC opinion

  Further Information Favourable Opinion