NCT00828750已完成3 期
Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)-An Extension Study of Eltrombopag in Subjects, With Idiopathic Thrombocytopenic Purpura (ITP), Previously Enrolled in an Eltrombopag Study TRA108109 (NCT00540423)-<Phase III Study>
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category
研究概览
简要总结
An open-label, dose-adjustment extension study to evaluate the safety and efficacy of eltrombopag for treatment of subjects with ITP who have previously been enrolled in the eltrombopag trial TRA108109 (NCT00540423).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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 has signed and dated written informed consent.
- •Subject (>=20 years) diagnosed with ITP.
- •Subject previously enrolled in TRA108109 (NCT00540423) must have completed the treatment and follow-up periods as defined in that protocol.
- •Subject has no intercurrent medical event at risk of thrombosis such as thrombophilia.
- •Prolongation of prothrombin time and activated partial thromboplastin time (aPTT) must be within 1.2 times the upper limit of the normal range with no history of hypercoagulable state.
- •A complete blood count (CBC), within the reference range, with the following exceptions:
- •Hemoglobin: patients with haemoglobin level < the lower limit of normal are eligible for inclusion if hemorrhage is present.
- •Neutrophil count >= 1,500/L (1.5x10E9/L) is required for inclusion.
- •The following clinical chemistries MUST NOT exceed 1.2 times the upper limit of the normal reference range: creatinine, total bilirubin and alkaline phosphatase.
- •The following clinical chemistries MUST NOT exceed 2 times the upper limit of the normal reference range: ALT and AST.
- •Albumin must be not less than 80% of the lower limit of normal.
- •Female subjects must either be:
- •of non-childbearing potential (hysterectomy, bilateral oophorectomy, bilateral tubal ligation or post-menopausal > 1 year), or
- •of childbearing potential and have a negative pregnancy test and agree to use contraceptive methods specified in the GSK List of Highly Effective Methods for Avoidance of Pregnancy from two weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study:
- •Reticulocyte count within the reference range or elevated in case of bleeding.
排除标准
- •Any severe medical condition (cardiac, hepatic or renal disorder) other than chronic ITP. (Note: "Severe" is defined as >= Grade 3 as a rule according to the "Classification of the Severity of Adverse Experiences (PAB/SD Notification No.80, dated 29 June 1992)
- •History of suspected or confirmed arterial or venous thrombosis (e.g., myocardial infarction, deep vein thrombosis) within the last 1 year.
- •History of drug/alcohol abuse or dependence within the last 1 year.
- •Suspected blood disorder other than ITP.
- •Suspected platelet aggregation abnormality.
- •Suspected cyclic thrombocytopenia.
- •Suspected Evans Syndrome.
- •Subjects who met the GSK Liver Stopping Criteria in the previous eltrombopag study TRA108109 (NCT00540423).
- •Current or history of HIV infection or hepatitis B virus or hepatitis C virus infections.
- •Current malignancy or history of malignancy that was treated with chemotherapy or radiotherapy.
- •Female subjects who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
- •Subjects who are deemed unsuitable for the study by the investigator (or subinvestigator).
- •Treatment with an investigational drug within 30 days preceding the first dose of study medication.
- •Pre-existing cardiovascular disease, or arrhythmia known to increase the risk of thromboembolic events (e.g. atrial fibrillation).
研究组 & 干预措施
Treatment
Experimental
Eltrombopag oral tablets once daily
干预措施: Eltrombopag oral tablets (Drug)
结局指标
主要结局
Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category
时间窗: From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medical product, whether or not related to the product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or its prolongation, results in disability/incapacity, is a congenital anomaly/birth defect, or is another event considered serious. A drug-related AE is any AE that was judged to have a relationship with the study medication by the investigator. The severity of an AE is based on the investigator's clinical judgment.
次要结局
- Median Platelet Counts(Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982))
- Median Number of Maximum Continuous Weeks of Maintaining Platelet Counts Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count at Three-Month Intervals(3, 6, 9, 12, 15, 18, 21, 24, 27, and 30 months (13, 26, 39, 52, 65, 78, 91, 104, 117, and 130 weeks))
- Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L(Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982))
- Percentage of Participants Initiating Rescue Medication/Treatment During On-Therapy(From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days))
- Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)(From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days))
- Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication(Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982))
- Percentage of Participants With a Reduction in Use of Baseline Idiopathic Thrombocytopenic Purpura (ITP) Medication(From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days))
研究者
研究点 (1)
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