1423M0634: S-888711 in CLD Undergoing Invasive Procedures (L-PLUS-2)

  • Research type

    Research Study

  • Full title

    A Phase 3 Randomised, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of S-888711 (Lusutrombopag) for the Treatment of Thrombocytopenia in Patients with Chronic Liver Disease Undergoing Elective Invasive Procedures (L-PLUS 2)

  • IRAS ID

    178380

  • Contact name

    Gavin Wright

  • Contact email

    Gavin.Wright@btuh.nhs.uk

  • Sponsor organisation

    Shionogi Ltd

  • Eudract number

    2014-004942-91

  • Clinicaltrials.gov Identifier

    NCT02389621

  • Clinicaltrials.gov Identifier

    104047, IND Number

  • Duration of Study in the UK

    1 years, 7 months, 2 days

  • Research summary

    This study is being performed to determine the safety and efficacy (whether the study treatment works) and the pharmacokinetics (the way that the body handles the drug i.e. absorbs, circulates, breaks down and eliminates it) of a new drug called S-888711 (Lusutrombopag) in patients with Chronic Liver Disease and thrombocytopenia (a disorder where there is an abnormally low amount of platelets), who are scheduled to undergo elective (not required urgently) invasive procedures. Because these patients have a low platelet count, they may be at risk of bleeding during their surgical procedure. To reduce this risk, doctors measure the amount of the platelets in their blood (a so called platelet count) and if necessary give a platelet transfusion to increase this. Platelet transfusions can be associated with dangerous side effects. S-888771 can also increase platelet counts and the purpose of this study is to see, if by giving S-888711 patients will not need to have a platelet transfusion. S-888711 will be compared to placebo (an identical substance to S-888711 but contains no active ingredient) and the study drugs will be taken orally once daily for up to 7 days.

    The amount of time participants will be in the study may vary depending on the timing of tests/assessments and the scheduled invasive procedure.
    This study is made up of the following three periods:
    1. Screening Period (within 28 days before taking the study drugs).
    2. Treatment Period (7 days)
    3. Post-Treatment Period (for 28 days after the treatment period)

    The study will take place in the USA, Europe and Asia/Pacific countries. Approximately 200 patients will take part. A small group of up to 20 patients (chosen at random) will be selected for intensive pharmacokinetic blood sampling. This is to study in more detail how the study drug is absorbed into the bloodstream.

  • REC name

    London - London Bridge Research Ethics Committee

  • REC reference

    15/LO/0689

  • Date of REC Opinion

    17 Jun 2015

  • REC opinion

    Further Information Favourable Opinion