Lumiracoxib Pharmacogenetic Follow-up Study

• Research type

  Research Study

• Full title

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

• IRAS ID

  37899

• Contact name

  John Robinson

• Sponsor organisation

  Novartis Pharma-AG

• Eudract number

  2009-017148-15

• Research summary

  The purpose of this research is to follow up on patients who participated in previous clinical trials involving lumiracoxib. Consent will be sought only from patients who experienced elevated liver enzymes or liver toxicity in previous lumircoxib trials and exploratory genetic assessments will be performed by extracting DNA from a blood sample. The results of the research will be used to study the association between genetic variation and lumiracoxib-related liver toxicity as a means of improving the safety profile of lumiracoxib. The study population worldwide will consist of 37 male and female patients. In the UK, 3 potential patients have been identified however only one of these is still known to be alive and contactable.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  09/H1002/94

• Date of REC Opinion

  13 Jan 2010

• REC opinion

  Favourable Opinion