Status: Ongoing First registered on: 17/04/2013
Last updated on: 18/12/2013
1. Study identification
EU PAS Register NumberEUPAS3847
Official titleThe European Drug-induced Agranulocytosis Consortium Study
Study title acronymThe EuDAC Study
Study typeOther: Case-control
Brief description of the studyStudies 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.
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 nameClinical Pharmacology, Department of Medical Sciences, Uppsala University
Centre locationUppsala, Sweden
Details of (Primary) lead investigator
Title Dr
Last name Hallberg
First name Pär
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?11

LSHTM
Clinical Pharmacology at Karolinska
CESME
FICF
Erasmus MC Pharmacoepi
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
Countries in which this study is being conducted
International study

France
Germany
Netherlands
Spain
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/04/200801/04/2008
Start date of data collection01/03/200901/03/2009
Start date of data analysis01/06/2014
Date of interim report, if expected
Date of final study report01/12/2015
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 bodySwedish Medical Products Agency25
Research councilsUppsala County Council Research Fund, Sweden10
EU funding scheme
OtherSwedish research council25
Swedish Society of Medicine25
Serlander’s Fund, Sweden10
Thereus’ Fund, Sweden5
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Hallberg
First name Pär
Address line 1Clinical Pharmacology
Address line 2Entrance 61, 4th floor 
Address line 3Uppsala University Hospital 
CityUppsala 
Postcode751 85 
CountrySweden
Phone number (incl. country code)46-186110000 
Alternative phone number 
Fax number (incl. country code) 
Email address par.hallberg@medsci.uu.se
Public Enquiries
Title Dr 
Last name Hallberg 
First name Pär 
Address line 1Clinical Pharmacology 
Address line 2Entrance 61, 4th floor 
Address line 3Uppsala University Hospital 
CityUppsala 
Postcode751 85 
CountrySweden 
Phone number (incl. country code)46-186110000 
Alternative phone number 
Fax number (incl. country code) 
Email address par.hallberg@medsci.uu.se 
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