CTRI/2017/06/008898进行中（未招募）2 期
SOAR Trial, A two-part study: Interventional phase IIsingle-arm trial to assess efficacy and safety ofEltrombopag combined with cyclosporine as first linetherapy in patients with severe acquired aplastic anemia,and an extension with up to 60-months follow-up
ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Patient has signed the Informed Consent (ICF) prior to any screening procedures being performed
- •2. Patient is male or female more than 6 years old at the time of informed consent and able to swallow a tablet
- •3.Patient has SAA characterized by
- •Bone marrow cellularity less than 30% (excluding lymphocytes) and At least two of the following (peripheral blood):
- •Absolute neutrophil count less than 500 per microliter
- •Platelet count less than 20000 per microliter
- •Absolute reticulocyte count less than 60000 per microliter
- •4.Normal ECG defined as the following as determined via the mean of a triplicate ECG
- •Resting heart rate 6 to 12 years is 60 to 130 bpm 12 to 18 years is 60 to 120 bpm 18 years and above is 50 to 90 bpm
- •QTcF at screening less than 450 msec (male patients) 460 msec (female patients)
排除标准
- •1.Diagnosis of Fanconi anemia.
- •2.Evidence of a clonal hematologic bone marrow disorder on cytogenetics. Patients with very severe neutropenia (ANC less than 200 per microliter) will not be excluded initially if cytogenetics are not available or pending. If a clonal disorder is identified the patient will be excluded.
- •3.Prior immunosuppressive therapy with cyclosporine alemtuzumab rabbit or horse ATG and thrombopoietin receptor (TPO-R) agonists.
- •4.Hypersensitivity to eltrombopag or its components.
- •5.AST or ALT more than 3 x ULN.
- •6.Creatinine total bilirubin and alkaline phosphatase more than 3 x ULN .
- •7.Patient with liver cirrhosis.
- •8.Infection not adequately controlled with appropriate therapy.
- •9.Moribund status or concurrent hepatic renal cardiac neurologic pulmonary infectious or metabolic disease of such severity that it would preclude the patients ability to consent be compliant with study procedures tolerate protocol therapy or that death within 30 days is likely.
- •10.Patients with cancer who are not considered cure are on active chemotherapeutic treatment or who take drugs with hematological effects.
- •11.Administration of an investigational drug within 30 days or 5 half lives whichever is longer preceding the first dose of study treatment.
- •12.Pregnancy statements and contraception requirements:
- •Pregnancy or nursing (lactating) women Women of child-bearing potential defined as all women physiologically capable of becoming pregnant (or female partners of male patients) unless they are using highly effective methods of contraception during dosing and for 3 months after stopping medication.
- •13.Not able to understand the investigation nature of the study or to give informed consent.
- •14.Clinically significant ECG abnormality including cardiac arrhythmias (ventricular tachycardia) complete left bundle branch block high grade atrioventricular block or inability to determine the QTcF interval on the ECG.
- •15.Presence of cardiac disease or family history of idiopathic sudden death or congenital long QT syndrome.
- •16.Risk factors for Torsades de Pointe including uncorrected hypokalemia or hypomagnesemia or use of concomitant medication(s) with a known risk to prolong the QT interval that cannot be discontinued.
研究者
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