Thrombocytopenia in patients with Chronic Liver Disease (CLD) MedDRA version: 19.1 Level: PT Classification code 10043554 Term: Thrombocytopenia System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Product Name: Lusutrombopag
Product Code: S-888711
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Lusutrombopag
CAS Number: 1110766-97-6
Current Sponsor code: S-888711
Other descriptive
Sponsors
Shionogi Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Able to understand the study and comply with all the study procedures 2.Willing to provide written informed consent prior to Screening 3.Male or female 4.18 years of age or older at the time of signing informed consent 5.Platelet count =65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1.Any of the following diseases: •haematopoietic tumour •aplastic anaemia •myelodysplastic syndrome •myelofibrosis •congenital thrombocytopenia •drug induced thrombocytopenia •generalised infection requiring treatment except for viral liver disease •immune thrombocytopenia. 2.History of splenectomy. 3.History of liver transplantation. 4.Any of the following at Screening: •hepatic encephalopathy uncontrolled by drugs •ascites uncontrolled by drugs. 5.Portal vein tumour embolism. 6.Known to be positive for the human immunodeficiency virus. 7.Past or present thrombosis or prothrombotic condition (eg, cerebral infarction, myocardial infarction, angina pectoris, coronary artery stent placement, angioplasty, coronary artery bypass grafting, congestive heart failure [New York Heart Association {NYHA} Grade III/IV], arrhythmia known to increase the risk of thromboembolic events [eg, atrial fibrillation], pulmonary thromboembolism, deep vein thrombosis, or disseminated intravascular coagulation syndrome). 8.History or evidence of any of the following diseases: •congenital thrombotic disease (eg, antithrombin deficiency, protein C deficiency, protein S deficiency, or coagulation factor [Factor V Leiden] mutation) •acquired thrombotic disease (eg, antiphospholipid antibody syndrome, paroxysmal nocturnal haemoglobinuria, hyperhomocysteinaemia, or increased factor VIII) •Budd Chiari syndrome. 9.Portal vein thrombosis based on ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI) within 28 days prior to randomisation or a history of portal vein thrombosis. 10.Absence of hepatopetal blood flow in the main trunk of the portal vein as demonstrated by Doppler ultrasonography within 28 days prior to randomisation. 11.History or evidence of disease associated with a risk of bleeding (eg, coagulation factor deficiency or von Willebrand factor deficiency). 12.Bleeding score at randomisation = Grade 2 according to the World Health Organization (WHO) Bleeding Scale. 13.Any of the following drugs or therapies within 90 days prior to randomisation: •anticancer drugs •interferon preparations •radiation therapy •exsanguination •other TPO receptor agonist •any investigational agent. 14.Any invasive procedure within 14 days prior to randomisation. 15.Blood transfusion within 14 days prior to randomisation. 16.Patients who have received S-888711 before. 17.Pregnant or lactating female. 18.Patients with known or suspected ongoing, active alcohol or substance abuse. Patients with a recent history who the investigator feels are able to comply with the study procedures and medications will be allowed to participate. 19.Considered ineligible by the investigator for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of S-888711 with placebo for the treatment of thrombocytopenia in patients with CLD who are undergoing elective invasive procedures;Secondary Objective: •To assess the safety and tolerability of S-888711 treatment compared with placebo •To assess the platelet response following treatment with S-888711 compared with placebo •To assess the pharmacodynamics and pharmacokinetics of S-888711;Primary end point(s): •Proportion of patients who require no platelet transfusion prior to the primary invasive procedure and no rescue therapy for bleeding from randomisation through 7 days after the primary elective procedure.;Timepoint(s) of evaluation of this end point: On or after Day 8, but no more than 2 days prior to the elective invasive procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Proportion of patients who require no platelet transfusion during the study •Proportion of responders: patients who achieve a platelet count of = 50 × 109/L with an increase of = 20 × 109/L from baseline at any time during the study •Duration of the platelet count defined as the number of days during which the platelet count was maintained as = 50 × 109/L •Proportion of patients who require rescue therapy for bleeding at any time during the study •Frequency of platelet transfusions •The change from baseline in platelet count over time (time course of platelet count) •Safety and tolerability •Assessment of plasma concentrations of S-888711;Timepoint(s) of evaluation of this end point: 63 days | — |
Countries
Argentina, Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Poland, Romania, Russian Federation, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactCorporate Communications Department
Shionogi & Co., Ltd
Outcome results
None listed