EUCTR2007-005851-40-BE进行中（未招募）不适用
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
GlaxoSmithKline Research and Development Ltd0 个研究点目标入组 500 人开始时间: 2008年3月12日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects eligible for enrolment in the study must meet all of the following criteria:
- •1. Male and female subjects, =18 years of age with chronic liver disease.
- •2. Child-Pugh score of 12 or less
- •3. Model of End Stage Liver Disease (MELD) score of 24 or less. 25 -
- •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/µL.
- •6. A baseline serum sodium level >130mEq/L.
- •7. Haemoglobin concentration >8g/dL stable for at least one month.
- •8. 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 greater 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 for two weeks before exposure to the study drug, throughout the clinical study, and for 28 days after completion or premature discontinuation from the study to account for the elimination of the study drug (minimum of 5 half-lives).
- •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 (either combined or progesterone only).
- •Any other contraceptive method with a documented failure rate of <1% per year.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects meeting any of the following criteria must not be enrolled in the study:
- •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
- •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.
- •10. Previous participation in TPL104054.
研究者
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