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Clinical Trials/EUCTR2009-017148-15-IT
EUCTR2009-017148-15-IT
Active, not recruiting
Not Applicable

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 sites37 target enrollmentApril 23, 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
patients with elevated liver enzymes (Hy s law cases or AST/ALT > 10x
Sponsor
OVARTIS FARMA
Enrollment
37
Status
Active, not recruiting
Last Updated
14 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 23, 2010
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Not specified

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