NL-OMON50032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> - CETB115E2403, SOAR trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- ovartis
- 入组人数
- 2
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
- 年龄范围
- 18 至 64（—）
入选标准
- •Male and female >= 18 years of age.
- •Severe aplastic anemia 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 <20000/ µL
- •- Absolute reticulocyte count <60000/ µL
- •Normal ECG (see protocol page 40 for details).
排除标准
- •Fanconi anemia.
- •Evidence of a clonal hematologic bone marrow disorder. See protocol page 40
- •for details.
- •Prior immunosuppressive therapy with cyclosporine, alemtuzumab, r- or h-ATG
- •and TPO-R agonists.
- •Liver cirrhosis.
- •Infection not adequately controlled with appropriate therapy.
- •Moribund or concurrent hepatic, renal, cardiac, neurologic, pulmonary,
- •infectious, cancer or metabolic disease of such severity that it would
- •interfere with a proper completion of study visits or treatment.
- •Pregnant or nursing (lactating) women.
- •Females and males not using adequate contraception. See protocol page 45 for
- •more details.
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 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
进行中（未招募）
1 期
Ex vivo drug sensitivity in metastatic colorectal cancerEUCTR2020-003395-41-NOOslo University Hospital45
招募中
1 期
EVIDENTColorectal cancerMedDRA version: 21.0Level: PTClassification code: 10052358Term: Colorectal cancer metastatic Class: 100000004864CTIS2023-510092-62-00Oslo University Hospital HF45
进行中（未招募）
不适用
MESOT-TREM-2012EUCTR2012-002762-12-ITAZIENDA OSPEDALIERA SENESE