HLA alleles as genetic risk factors for elevation of aminotransferase levels in patients treated with agomelatine

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Other
• If ‘other’, further details on the scope of the study:
  Pharmacogenomy
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Case-control

  Other
• Non-interventional study design, other:
  Pharmacogenomics

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N06AX22) agomelatine

  agomelatine
• Medical condition to be studied:
  Major depression

  Generalised anxiety disorder

Population studied

• Short description of the study population:
  Patients treated with agomelatine.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  84

Study design details

• Main study objective:
  To assess and investigate the relevance of certain genetic susceptibility factors (HLA allelic variants) to the increased serum transaminases (>3ULN) seen in some patients treated with agomelatine.
• Outcomes:
  Genotype for selected HLA genes (HLA class I : A, B and C genes and HLA class II : DRB1, DQA1, DQB1, and DPB1genes)
• Data analysis plan:
  For each HLA gene, the association between genotype and case / control status will be evaluated with a logistic regression model. Based on this method an Odds-Ratio with its 95% CI and a p-value will be provided.