phase 2, pharmacokinetics study of eltrombopag in japanese thrombocytopenic subjects with chronic liver disease

Conditions: Liver Diseases

Summary: this is an open label, multi-centre, dose ranging study to assess efficacy, safety and pharmacokinetics of eltrombopag in thrombocytopenic subjects with chronic liver disease.


Eligibility criteria:
inclusion criteria: * subject who agree to comply with protocol requirements and instructions and who provide signed and dated written informed consent. * male and female subjects, ≥20 years of age (at the time of informed consent) with chronic liver disease. * child-pugh score \<=9. * a baseline platelet count \<50,000/mcl. * a baseline serum sodium level \>130 meq/l. * haemoglobin concentration \>8 g/dl, stable for at least 4 weeks. * a female is eligible to enter and participate in the study if she is of: non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any female who: * has had a hysterectomy * has had a bilateral oophorectomy (ovariectomy) * has had a bilateral tubal ligation * is post-menopausal (demonstrate total cessation of menses for longer than one year) childbearing potential, has a negative urine and/or serum pregnancy test at screening, and within the 24 hour period prior to the first dose of investigational product and uses one of the following acceptable methods of contraception: * complete abstinence from intercourse. * any intrauterine device (iud) with a documented failure rate of less than 1% per year. * double-barrier contraception (condom with spermicidal jelly, or diaphragm with spermicide). * male partner who is sterile (diagnosed by a qualified medical professional) prior to the female subject's study entry and is the sole sexual partner for that female. * oral contraceptive (combined). * subject has no physical limitation to ingest and retain oral medication. exclusion criteria: * subjects with known or suspected hypersensitivity, intolerance or allergy to any of the ingredients in eltrombopag tablets. * evidence of portal vein thrombosis on abdominal imaging (ultrasound with doppler or appropriate magnetic resonance imaging/computed tomography (mri/ct) imaging techniques) within 3 months before the start of the study. * history of arterial or venous thrombosis (including budd-chiari syndrome), and ≥ two of the following risk factors: * hereditary thrombophilic disorders (e.g. antithrombiniii (atiii) deficiency, etc.) * hormone replacement therapy * systemic contraception therapy (containing oestrogen) * smoking * diabetes * hypercholesterolemia * medication for hypertension or cancer * human immunodeficiency virus (hiv) infection. * history of drug/alcohol abuse or dependence within 1 year prior to screening. * any disease condition associated with current active world health organization (who) grade 3 or 4 bleeding. * active infection requiring systemic antibiotic therapy. * pregnant, nursing mothers, women who may be pregnant, or women who plan to become pregnant during the time of study participation. * treatment with platelet transfusion within 2 weeks prior to day 1. * treatment with interferon within 4 weeks prior to day 1. * treatment with an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication. * history of platelet agglutination abnormality. * history of porphyria. * subjects who are deemed unsuitable for the study by the investigator (or subinvestigator).