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临床试验/JPRN-jRCT2080225007
JPRN-jRCT2080225007招募中4 期

An open label, multi-center, Phase IV rollover protocol for patients who have completed a prior global Novartis or Incyte sponsored ruxolitinib (INC424) study or ruxolitinib and panobinostat (LBH589) combination study, and are judged by the investigator to benefit from continued treatment

ovartis Pharma. K.K.0 个研究点目标入组 356 人开始时间: 2020年1月8日最近更新:
适应症

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
356

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
>= 12age old 至 ot applicable(—)
性别
All

入选标准

  • Male and female patients who are currently enrolled in a Novartis-sponsored study or Incyte-sponsored study that has reached its study objectives, who are not progressing on the current study treatment as defined by the parent protocol, have completed their obligations in the parent study and are unable to access ruxolitinib or combination of ruxolitinib and panobinostat outside of a clinical study. Patients must be benefiting from treatment as judged by the investigator at the completion of the parent study.

排除标准

  • Patient has been permanently discontinued from study treatment in the parent study due to any reason.
  • Patient indication is currently approved and reimbursed in the corresponding country for ruxolitinib monotherapy or combination of ruxolitinib and panobinostat

研究者

发起方
ovartis Pharma. K.K.

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