Study identification

PURI

https://redirect.ema.europa.eu/resource/3848

EU PAS number

EUPAS3847

Study ID

3848

Official title and acronym

The European Drug-induced Agranulocytosis Consortium Study (The EuDAC Study)

DARWIN EU® study

No

Study countries

France
Germany
Netherlands
Spain
Sweden
United Kingdom

Study description

Studies show that adverse drug reactions (ADRs) are one of the most common reasons for hospitalisation in the adult population. It has also been proposed that ADRs are the fourth to sixth leading cause of death in hospitalised patients. Most ADRs are dose-dependent and pharmacologically predictable (type A reactions), while others have no known pharmacological cause (type B reactions). Agranulocytosis (unless due to chemotherapy) belongs to this second type that commonly is serious and sometimes leads to withdrawal of drugs from the market. The current knowledge about possible genetic causes of drug-induced agranulocytosis is minimal. The aim of EuDAC is to identify genetic factors that predispose to drug-induced agranulocytosis, enabling us to test and predict the individual risk before starting a drug treatment.

Study status

Ongoing
Research institutions and networks

Institutions

Clinical Pharmacology,Department of Medical Sciences
Clinical Pharmacology Service, University of Málaga Spain, Medical Products Agency Sweden, Instituto de Parasitología y Biomedicina López Neyra Avda Spain, Clinical Pharmacology, Uppsala University Sweden, Laboratoire de Pharmacologie Médicale et Clinique, Faculté de Médecine de l’Université de Toulouse France, Charité - University Medicine, Institute of Clinical Pharmacology and Toxicology, Berlin Germany

Contact details

Pär Hallberg

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

Swedish Medical Products Agency, Uppsala County Council Research Fund, Sweden, Swedish research council, Swedish Society of Medicine, Serlander’s Fund, Sweden, Thereus’ Fund, Sweden
Study protocol
Initial protocol

The EuDAC Study 2013-12-03

English (536.09 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No