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临床试验/EUCTR2014-003527-22-ES
EUCTR2014-003527-22-ES进行中（未招募）1 期

An open label, multi-center, Phase IV roll-over protocol for patients who have completed a prior global Novartis or Incyte sponsored ruxolitinib (INC424) study and are judged by the investigator to benefit from continued treatment

ovartis Farmacéutica, S.A.0 个研究点目标入组 96 人开始时间: 2015年3月11日最近更新:
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适应症
相关药物

试验速览

阶段
1 期
状态
进行中（未招募）
发起方
入组人数
96
研究概览入排标准研究者记录与标识符相似试验

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

  • •- Patient is currently enrolled in a Novartis OGD or GMA-sponsored or Incyte-sponsored clinical study (where Incyte can delegate the sponsorship to a preferred CRO, if applicable) that is approved to enroll into this rollover study, is receiving ruxolitinib and has fulfilled all of the requirements of the parent protocol.
  • •- Patient is currently benefiting from the treatment with ruxolitinib, as determined by the investigator
  • •- Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements
  • •- Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures
  • •- Patient currently has no evidence of progressive disease, as determined by the investigator, following previous treatment with ruxolitinib
  • •- Written informed consent obtained prior to enrolling in roll-over study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.
  • •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 24
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 72

排除标准

  • •- Patient has been permanently discontinued from study treatment in the parent study due to any reason.
  • •- Patient?s indication is currently approved and reimbursed in the local country
  • •- Patient has participated in a combination trial where ruxolitinib was dispensed in combination with another study medication and the patient is still receiving combination therapy.
  • •- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
  • •- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study duration inclusive of the 30-day safety follow up. Highly effective contraception methods include: see protocol.

研究者

发起方
ovartis Farmacéutica, S.A.

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