patients with elevated liver enzymes (Hy s law cases or AST/ALT > 10x ULN
Conditions
Interventions
Product Name: lumiracoxib
Product Code: COX189A
Pharmaceutical Form: Dispersible tablet
INN or Proposed INN: Lumiracoxib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration num
Sponsors
NOVARTIS FARMA
Eligibility
Sex/Gender
All
Inclusion 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
Exclusion criteria: 1. Patients who do not provide written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed