EUCTR2016-002814-29-NL进行中（未招募）1 期
SOAR, Interventional phase II single-arm study to assess efficacy and safety of eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemia - SOAR
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- •1.Patient has signed the Informed Consent (ICF) prior to any screening procedures being performed.
- •2.Patient is male/female =18 years old at the time of informed consent and able to swallow a tablet.
- •3.Patient has SAA characterized by:
- •a.Bone marrow cellularity <30% (excluding lymphocytes) and
- •b.At least two of the following (peripheral blood):
- •Absolute neutrophil count <500/ µL
- •Platelet count <20,000/ µL
- •Absolute reticulocyte count <60,000/ µL
- •4.Normal ECG defined as the following as determined via the mean of a triplicate ECG
- •Resting heart rate
- •6-<12 years: 60-130 bpm
- •12-<18 years: 60-120 bpm
- •=18 years: 50-90 bpm
- •QTcF at screening <450 msec (male patients), 460 msec (female patients)
- •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 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.Diagnosis of Fanconi anemia.
- •2.Evidence of a clonal hematologic bone marrow disorder on cytogenetics by central review.
- •3.Prior immunosuppressive therapy with cyclosporine, alemtuzumab, rabbit or horse ATG and thrombopoietin receptor (TPO-R) agonists.
- •4. a. Hypersensitivity to eltrombopag or cyclopsorine or their components.
- •b. Contraindications to cyclosporine
- •5.AST or ALT >3 x ULN.
- •6.Serum creatinine, total bilirubin, and alkaline phosphatase >1.5 x ULN.
- •7.Patient with liver cirrhosis.
- •8.a. Infection not adequately controlled with appropriate therapy.
- •8.b. Patients who are human immune deficiency virus (HIV), hepatitis C virus or hepatitis B surface antigen (HBsAg) positive. HCV-RNA negative patients are allowed to be enrolled.
- •9.Moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the patient's ability to consent, be compliant with study
- •procedures, tolerate protocol therapy, or patients with less than 3 months of life expectancy.
- •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.
- •In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
- •13.Not able to understand the investigation nature of the study or to give informed consent.
- •14.Clinically significant ECG abnormality including cardiac arrhythmias (e. g. 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 or replaced by safe alternative medication per www.qtdrugs.org.
- •17. ECOG performance status of =2.
- •18. Patients under the age of 40 must be referred for consideration of allogeneic bone marrow transplantation (HSCT) if (human leukocyte antigen) HLA matching has been done and a suitable matched sibling donor is available and the patient is willing to undergo transplantation (i.e. patients who do not have a HLA match or are not medically fit, not willing or unable to undergo transplantation will be considered for enrollment).
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