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

Study identification

• EU PAS number:
  EUPAS10039
• Study ID:
  28494
• Official title and acronym:
  HLA alleles as genetic risk factors for elevation of aminotransferase levels in patients treated with agomelatine
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  To assess and investigate some susceptibility factors (allelic variants of HLA system) for agomelatine’s effect on serum aminotransferase levels
• Study status:
  Finalised

Research institutions and networks

Institutions

DALY

Study timelines

Date when funding contract was signed

Actual:15/05/2014

Study start date

Actual:20/04/2009

Date of final study report

Planned:30/09/2016

Actual:26/09/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Les Laboratoires Servier

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)