临床试验/NCT01289054

NCT01289054已完成不适用

A Global Imatinib and Nilotinib Pregnancy Exposure Registry A Post-Authorisation Safety Study (PASS)

Novartis Pharmaceuticals1 个研究点分布在 1 个国家目标入组 4 人开始时间: 2011年1月最近更新: 2015年4月15日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Novartis Pharmaceuticals
入组人数: 4
试验地点: 1
主要终点: Monitor pregnancies exposed to Imatinib or Nilotinib to estimate prevalence of birth defects

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a voluntary, international, primarily prospective, observational, exposure-registry and follow-up study of women receiving Imatinib and Nilotinib during pregnancy or within six months prior to pregnancy.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

性别: Female
接受健康志愿者: 否

入选标准

•Provide sufficient evidence to confirm that exposure occurred during pregnancy or within 6 months prior to exposure.
•Be at least 18 years of age
•Reside in a country supported by the Registry

排除标准

•Cases that do not meet the eligibility criteria are deemed ineligible, including paternal exposures
•Other protocol-defined inclusion/exclusion criteria may apply

研究组 & 干预措施

Cohort 1 - Pregnancy/Fetal Exposure

干预措施: Tasigna (Drug)

Cohort 1 - Pregnancy/Fetal Exposure

干预措施: Gleevec (Drug)

结局指标

主要结局

Monitor pregnancies exposed to Imatinib or Nilotinib to estimate prevalence of birth defects

时间窗: During pregnancy or within 6 months prior to conception

次要结局

Assess impact on maternal CML disease when treatment is interrupted(During pregnancy or within 6 months prior to conception)
Assess post 12 month post-delivery data on maternal and infant status(12 months after birth)

研究者

发起方

Novartis Pharmaceuticals

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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