NCT00861601已完成2 期
TPL111913, a Multi-centre, Open Label, Dose Ranging Phase II Study to Assess Efficacy, Safety and Pharmacokinetics of Eltrombopag in Japanese Thrombocytopenic Subjects With Chronic Liver Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change From Baseline in Platelet Counts on Day 15
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 <=
- •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.
排除标准
- •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)
- •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
- •Treatment with interferon within 4 weeks prior to Day
- •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).
研究组 & 干预措施
low dose
Experimental
eltrombopag 12.5 mg/day
干预措施: eltrombopag 12.5 milligrams (mg) tablet (Drug)
middle dose
Experimental
eltrombopag 25 mg/day
干预措施: eltrombopag 25 mg tablet (Drug)
high dose
Experimental
eltrombopag 37.5 mg/day
干预措施: eltrombopag 12.5 milligrams (mg) tablet (Drug)
high dose
Experimental
eltrombopag 37.5 mg/day
干预措施: eltrombopag 25 mg tablet (Drug)
结局指标
主要结局
Change From Baseline in Platelet Counts on Day 15
时间窗: Baseline, Day 15
Platelet counts were measured by blood draw. Change from Baseline was calculated as the Day 15 value minus the Baseline value.
次要结局
- Platelet Counts by Post-Treatment Visit(4 days post-treatment, 8 days post-treatment, and 15 days post-treatment)
- Analysis of Covariance for Three Patterns of Dose Response Using the Change From Baseline in Platelet Counts (Baseline Platelet Counts as Covariate)(Baseline, Day 15)
- Change From Baseline in Platelet Counts by Post-Treatment Visit(4 days post-treatment, 8 days post-treatment, and 15 days post-treatment)
- Percentage of Responders on Day 22(Day 22)
- Log-transformed Cmax on Days 14 and 15 in Participants Receiving Eltrombopag 12.5 mg(Day 14, Day 15)
- Log-transformed Tmax on Days 14 and 15 in Participants Receiving Eltrombopag 12.5 mg(Day 14, Day 15)
- Analysis of Covariance for Three Patterns of Dose Response Using the Change From Baseline in Platelet Counts (Baseline of Platelet Counts and Child-Pugh Class as Covariates)(Baseline, Day 15)
- Platelet Counts at Day 22(Day 22)
- Percent Change From Baseline in Platelet Counts on Day 15(Baseline, Day 15)
- Platelet Counts by Treatment Visit(Day 1 (Baseline), Day 8, Day 15, and Final Assessment Point (Day 15 or Day 22))
- Log-transformed AUC(0-t) and AUC(0-24) on Days 14 and 15 in Participants Receiving Eltrombopag 12.5 mg(Day 14, Day 15)
- Change From Baseline in Platelet Counts by Treatment Visit(Baseline, Day 8, Day 15, and Final Assessment Point (Day 15 or Day 22))
- Percentage of Responders on Day 15(Day 15)
- Change From Baseline in Platelet Counts on Day 15 by Sex(Baseline, Day 15)
- Change From Baseline in Platelet Counts on Day 15 by Age(Baseline, Day 15)
- Change From Baseline in Platelet Counts on Day 15 by Child-Pugh Class(Baseline, Day 15)
研究者
研究点 (1)
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