Status: Ongoing First registered on: 27/10/2010
Last updated on: 29/10/2010
1. Study identification
EU PAS Register NumberEUPAS1661
Official titleCHARACTERISATION OF PROTEOMIC PROFILES PREDICTIVE OF HEPATOTOXICITY ASSOCIATED WITH ANTI-TUBERCULOSIS DRUGS: A PILOT STUDY
Study title acronym
Study typeObservational study
Brief description of the studyTuberculosis represents nowadays one of the main problems in public health both in non-developed as in developed countries. The increase of the incidence of tuberculosis during the last years has been related to an increase in complications derived from its treatment, based on the use of isoniazid, rifampicin and pyrazinamide, as well as to the appearance of resistance, therapeutic failure or hepatotoxicity. In particular, hepatotoxicity due to anti-tuberculous drugs is a relevant problem for the scientific community as it results in the modification of the treatment and in liver transplantation or death in the most extreme situations. We propose the study of a cohort of patients who initiate treatment or profilaxis with antituberculous drugs, with the aim of identifying those presenting a high risk of developing hepatotoxicity. Therefore, we propose the analysis of the serum proteomic profiles of these patients. The main goal is the identification and characterisation of biological markers which would be predictive of hepatotoxicity associated with anti-tuberculous drugs.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsFICF
Department/Research group
Organisation/affiliationFundació Institut Català de Farmacologia
Website/Homepagewww.icf.uab.cat
Details of (Primary) lead investigator
Title Dr
Last name Ibáñez
First name Luisa
Is this study being carried out with the collaboration of a research network?
Yes
Hepatox-TBCGroup
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?5

Hospital Clinic Barcelona
Hospital de Sant Pau, Barcelona
Hospital del Mar, Barcelona
Unidad de Prevención y Control de la Tuberculosis (CAP Drassanes), Barcelona
Countries in which this study is being conducted
National study

Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed16/12/2008
Start date of data collection01/04/200901/09/2009
Start date of data analysis
Date of interim report, if expected
Date of final study report31/12/2012
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyICS and FIS100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Ibáñez
First name Luisa
Address line 1Vall d'Hebron 119-129
Address line 2Antiga Escola Infermeria 
Address line 3Servei de Farmacologia Clínica 
CityBarcelona 
Postcode08035 
CountrySpain
Phone number (incl. country code)34934894105 
Alternative phone number 
Fax number (incl. country code) 
Email address li@icf.uab.cat
Public Enquiries
Title Dr 
Last name Ibáñez 
First name Luisa 
Address line 1Vall d'Hebron 119-129 
Address line 2Antiga Escola Infermeria 
Address line 3Servei de Farmacologia Clínica 
CityBarcelona 
Postcode08035 
CountrySpain 
Phone number (incl. country code)34934894105 
Alternative phone number 
Fax number (incl. country code) 
Email address li@icf.uab.cat 
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