CHARACTERISATION OF PROTEOMIC PROFILES PREDICTIVE OF HEPATOTOXICITY ASSOCIATED WITH ANTI-TUBERCULOSIS DRUGS: A PILOT STUDY

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Other
• If ‘other’, further details on the scope of the study:
  Characterisation of proteomic profiles

Non-interventional study

• Non-interventional study design:
  Case-control

Study drug and medical condition

• Medical condition to be studied:
  Hepatotoxicity

Population studied

• 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:
  500

Study design details

• Main study objective:
  Characterisation of proteomic profiles
• Outcomes:
  The main goal is the identification and characterisation of biological markers which would be predictive of hepatotoxicity associated with anti-tuberculous drugs. To determine plasma protein levels before the treatment, at 21 days after initiation the treatment and at the end of the treatment.
• Data analysis plan:
  Data analysis plan- Cox regression model for Hazard rate estimation.- Close monitoring of included and excluded patients in each participating centre.- Use of structured questionnaire for retrieval of drug use.- Use of Cox regression model for risk and confounding factors.- Inclusion of centers with the highest follow-up rate of tuberculosis in Barcelona area.