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

• Conditions: patients with elevated liver enzymes (Hy s law cases or AST/ALT > 10x

• Registration Number: EUCTR2009-017148-15-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 37

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this post-hoc pharmacogenetic sub-study is to determine whether patients who experienced severe hepatotoxicity when taking lumiracoxib are carriers of the DQA1*0102 allele.;Secondary Objective: The secondary objective of this study is to determine whether Hy s law patients are carriers of the UGTA1*28 allele (and therefore may be affected by Gilbert syndrome).;Primary end point(s): Presence/absence of the DQA1*0102 allele.