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
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.
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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