Study identification

PURI

https://redirect.ema.europa.eu/resource/1662

EU PAS number

EUPAS1661

Study ID

1662

Official title and acronym

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

DARWIN EU® study

No

Study countries

Spain

Study description

Tuberculosis 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.

Study status

Ongoing
Research institution and networks

Institutions

Hospital de Sant Pau Barcelona, Hospital del Mar Barcelona, Unidad de Prevención y Control de la Tuberculosis (CAP Drassanes) Barcelona

Networks

Hepatox-TBCGroup

Contact details

Luisa Ibáñez

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

ICS and FIS
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable