NL-OMON50357撤回2 期
A phase II, open-label, non-controlled, intra-patient dose-escalation study to characterize the pharmacokinetics after oral administration of eltrombopag in pediatric patients with refractory, relapsed or treatment naïve severe aplastic anemia or recurrent aplastic anemia (CETB115E2201) - ETB115E2201
适应症
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
- 2 至 17（—）
入选标准
- •* Cohort-specific criteria: see protocol page 46.
- •* Male and female 1 up to 18 years.
- •* Aplastic anemia.
- •* Hematopoietic stem cell transplantation not suitable or available as a
- •treatment option or has been refused by the subject.
- •* Bone marrow aspirate and biopsy at any time during the 4 weeks prior to first
- •dose of eltrombopag.
- •* Normal karyotype with FISH for chromosomes 7 and 8.
- •* Performance status score: Karnofsky *50 for patients 16 years of age and
- •older or Lansky *50 for patients below 16 years of age.
排除标准
- •* Prior and/or active history of several diseases, see protocol page 47 for
- •* Active infection not responding to appropriate therapy.
- •* Prior eltrombopag or other thrombopoietin receptor (TPO-R) agonist treatment
- •for at least 2 months and a lack of response.
- •* Impaired cardiac function. See protocol page 48 for details.
- •* Pregnant or nursing (lactating) women.
- •* Females of childbearing potential and males not using adequate contraception.
- •See protocol page 48 for more details.
研究者
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