EUCTR2016-002814-29-HU进行中（未招募）1 期
SOAR Trial, A two-part study: Interventional phase II single-arm trial to assess efficacy and safety of Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia, and an extension with up to 60-months follow-up. - SOAR
适应症
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 =6 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 (for male patients), 460 msec (for female patients)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •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. Patients with very severe neutropenia (ANC < 200 /µL) 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. 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.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 patient’s 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.
- •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.
研究者
相似试验
进行中（未招募）
1 期
SOAR Trial: Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia with follow-up up to 60-months.EUCTR2016-002814-29-ESovartis Farmacéutica, S.A50
进行中（未招募）
2 期
Eltrombopag Combined With Cyclosporine (antibiotic) as First Line Therapy in Patients With Severe Acquired Aplastic AnemiaCTRI/2017/06/008898ovartis Healthcare Pvt Ltd
进行中（未招募）
1 期
SOAR Trial: Eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemia with follow-up up to 24-months.EUCTR2016-002814-29-NLovartis Pharma AG50
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 anemiaFirst-line severe aplastic anaemiaMedDRA version: 20.0Level: PTClassification code 10002967Term: Aplastic anaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2016-002814-29-ITOVARTIS PHARMA AG50
撤回
2 期
SOAR Trial 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.<br>NL-OMON50032ovartis2