跳至主要内容
临床试验/EUCTR2009-017148-15-IT
EUCTR2009-017148-15-IT进行中(未招募)不适用

A retrospective pharmacogenetic analysis of patients with elevated liver enzymes (Hy s law cases or AST/ALT > 10x ULN) in clinical studies CCOX189A0117, CCOX189A2332, CCOX189A2369, CCOX189A0126, CCOX189A0112, CCOX189A0109 or CCOX189A2361 - ND

OVARTIS FARMA0 个研究点目标入组 37 人开始时间: 2010年4月23日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
OVARTIS FARMA
入组人数
37

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

  • Inclusion criteria Patients eligible for inclusion in this study have to fulfill all of the following criteria: 1. Patients who received lumiracoxib and experienced a Hy s law or AST/ALT > 10xULN event after initiating treatment in clinical studies CCOX189A0117, CCOX189A2332, CCOX189A2369, CCOX189A0126, CCOX189A0112, CCOX189A0109 or CCOX189A2361. 2. Written informed consent must be obtained before any assessment is performed. Only patients who agree to participate in this pharmacogenetic post-hoc study by signing the informed consent form will be included in this study.
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1. Patients who do not provide written informed consent.

研究者

发起方
OVARTIS FARMA

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