a Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Study to Evaluate the Safety and Efficacy of Eltrombopag to Reduce the Need for Platelet Transfusion in Thrombocytopenic Subjects with Chronic Liver Disease Undergoing Elective Invasive Procedures. ELEVATE: ELtrombopag EValuated for its Ability to overcome Thrombocytopenia and Enable procedures - ELEVATE

GlaxoSmithKline Research and Development Ltd0 个研究点目标入组 500 人开始时间: 2008年4月16日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1.Male and female subjects, ≥18 years of age with chronic liver disease.
•2.Child-Pugh score of 12 or less (See Appendix 3).
•3.Model of End Stage Liver Disease (MELD) score of 24 or less.
•4.Subjects who, in the opinion of the investigator, are appropriate candidates to undergo an elective invasive procedure and who require a platelet transfusion to manage the risk of bleeding associated with the procedure.
•5.A baseline platelet count <50,000/mL.
•6.A baseline serum sodium level >130mEq/L.
•7.Haemoglobin concentration >8g/dL stable for at least one month.
•9.Subject has no physical limitation to ingest and retain oral medication.
•10.Subject is able to understand and comply with protocol requirements and instructions and is likely to complete the study as planned.
•11.Subject is able to provide signed and dated written informed consent.
•12.In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1.Subjects with a known hypersensitivity, intolerance or allergy to any of the ingredients in eltrombopag tablets.
•2.Evidence of portal vein thrombosis on abdominal imaging (ultrasound with Doppler or appropriate MRI/CT imaging techniques) within 3 months of study start.
•3.History of arterial or venous thrombosis, including Budd-Chiari Syndrome, AND ≥ two of the following risk factors: hereditary thrombophilic disorders (e.g. Factor V Leiden, ATIII deficiency, etc.), hormone replacement therapy, systemic contraception therapy (containing oestrogen), smoking, diabetes, hypercholesterolemia, medication for hypertension or cancer.
•4.Any disease condition associated with current active WHO Grade 3 or 4 bleeding (See Appendix 4 and study procedures manual [SPM]).
•5.Active infection requiring systemic antibiotic therapy. Prophylactic use of antibiotics is permitted.
•6.Pregnant or nursing women.
•7.Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication.
•8.History of platelet agglutination abnormality that prevents reliable measurement of platelet counts.
•9.History of porphyria.

发起方

GlaxoSmithKline Research and Development Ltd