NCT00678587终止3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 292
- 试验地点
- 1
- 主要终点
- Number of Participants With Chronic Liver Disease and Thrombocytopenia (Platelets <50 Gi/L) Who do Not Require a Platelet Transfusion Prior to, During, and up to 7 Days Following Elective Invasive Procedures
研究概览
简要总结
The purpose of this study is to assess the ability of eltrombopag to elevate platelet counts thereby reducing the need for platelet transfusions in chronic liver disease patients with thrombocytopenia undergoing elective invasive procedures. The clinical benefit of eltrombopag will be measured by the proportion of subjects who avoid platelet transfusions, before, during and up to 7 days after undergoing an invasive procedure. In addition, bleeding events will be monitored during this time. The number of transfusions, safety events and medical resource utilisation will be monitored during this time and for up to 30 days after undergoing an invasive procedure to help further evaluate clinical benefit.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects, 18 years of age or more with chronic liver disease.
- •Child-Pugh score of 12 or less.
- •Model of End Stage Liver Disease (MELD) score of 24 or less.
- •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.
- •A baseline platelet count <50,000/µL.
- •A baseline serum sodium level >130mEq/L.
- •Haemoglobin concentration >8g/dL stable for at least one month.
- •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.
- •Subject has no physical limitation to ingest and retain oral medication.
- •Subject is able to understand and comply with protocol requirements and instructions and is likely to complete the study as planned.
- •Subject is able to provide signed and dated written informed consent.
- •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.
排除标准
- •Subjects with a known 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 MRI/CT imaging techniques) within 3 months of study start.
- •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.
- •Any disease condition associated with current active WHO Grade 3 or 4 bleeding.
- •Active infection requiring systemic antibiotic therapy. Prophylactic use of antibiotics is permitted.
- •Pregnant or nursing women.
- •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 that prevents reliable measurement of platelet counts.
- •History of porphyria.
- •Previous participation in TPL104054.
研究组 & 干预措施
Placebo
Placebo Comparator
placebo, once daily, oral
干预措施: Placebo (Drug)
Active
Active Comparator
75 mg, once daily, oral
干预措施: Eltrombopag (Drug)
结局指标
主要结局
Number of Participants With Chronic Liver Disease and Thrombocytopenia (Platelets <50 Gi/L) Who do Not Require a Platelet Transfusion Prior to, During, and up to 7 Days Following Elective Invasive Procedures
时间窗: Prior to, during, and up to seven days following elective invasive procedures (Study Days 16-19); therefore, this covers a time period from Baseline to Day 26
A platelet transfusion was given if the platelet count was \<50 giga (10\^9) per liter (Gi/L) before the procedure. A platelet transfusion was not given if the platelet count was \>80 Gi/L (based on a primary endpoint of success). For participants with platelet counts between 50 Gi/L and 80 Gi/L, platelet transfusions were administered at the discretion of the investigator and the physician performing the elective invasive procedure.
次要结局
- Number of Participants With a World Health Organization (WHO) Bleeding Score >=2 During and up to 7 Days Following Elective Invasive Procedures(Prior to, during, and up to 7 days following elective invasive procedures (Study Days 16-19); therefore, this covers a time period from Baseline to Day 26)
- Number of Participants Experiencing an Adverse Event (AEs) and Serious Adverse Event (SAEs) Within the Indicated Category(Screening to Procedure +30 day follow-up or early withdrawal)
- Pharmacokinetics (PK) of Eltrombopag, Steady State AUC(0-tau)(Day 14)
- Number of Participants With the Indicated Number of Platelet Transfusions Administered(Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26)
- Median Platelet Count at Screening; Days 1, 8, 15, 16-19; Procedure + 7, 14, 21, 30 Day Follow-up; Early Withdrawal; and Maximum Post-baseline(Screening; Days 1, 8, 15, 16-19; Procedure + 7, 14, 21, 30 day follow-up; early withdrawal; and maximum post-baseline)
- Number of Participants With the Indicated Event Relating to Vision(Screening or Baseline and at End of Study (Procedure +30 day follow-up or withdrawal visit))
- Number of Participants With Renal Function Abnormality(Screening to Procedure +30 day follow-up or early withdrawal)
- Number of Participants With a Clinically Significant Change in Electrocardiogram (ECG) Results(Screening, Baseline, Day 15, and Withdrawal)
- Mean Number of Unscheduled Office Visits, Unscheduled Laboratory Tests, and Unscheduled Procedures(Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26)
- Number of Participants With the Indicated Platelet Count at Screening; Days 8 and 15; Procedure + 7, 14, 21, 30 Day Follow-up (FU); and Maximum Post-baseline(Screening; Days 8 and 15; Procedure + 7, 14, 21, 30 day follow-up; and maximum post-baseline)
- Number of Participants With a Serious Adverse Event That Occurred in Greater Than One Participant(Screening to Procedure +30 day follow-up or early withdrawal)
- Pharmacokinetics (PK) of Eltrombopag, CL/F(Day 14)
- Pharmacokinetics (PK) of Eltrombopag, Cmax(Day 14)
- Pharmacokinetics (PK) of Eltrombopag, t1/2(Day 14)
- Mean Number of Days Spent in the Hospital(Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26)
研究者
研究点 (1)
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