The principal aim of this project is to identify genetic biomarkers involved in susceptibility for drug-induced liver injury in a set of candidate genes (genes relevant to metabolism of drugs and immune system genes).The results of this study will…
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Variations in metabolic and immune genes between patients with drug-induced
liver injury and controls with no liver injury will be studied. Other variables
are patient characteristics like age and weight, alcohol and (recreational)
drug use.
Secondary outcome
None
Background summary
A wide variety of drugs can cause liver injury. Only a small proportion of
patients develop liver injury during treatment with commonly used medicines,
but the severity of the adverse drug reaction has been one of the main reasons
for withdrawal of drugs from the market. It is difficult to identify people who
are likely to suffer liver injury. Genetic susceptibility may be an important
risk factor for drug-induced liver injury. It would be of considerable benefit
if a test could be developed that could identify high risk patients.
Study objective
The principal aim of this project is to identify genetic biomarkers involved in
susceptibility for drug-induced liver injury in a set of candidate genes (genes
relevant to metabolism of drugs and immune system genes).
The results of this study will contribute to:
1. The ability to identify high risk-patients
2. Reduce the number of patients developing drug-induced liver injury
3. The establishment of a biobank, which will provide material for future
pharmacogenetic, proteomics and metabolomics studies
Study design
Case control study
Blood will be obtained from cases of drug-induced liver injury (DILI) and DNA
will be isolated. Genes relevant to DILI will be studied and compared with the
genetic profile of selected controls from existing databases.
Study burden and risks
Patients will donate once blood (17 ml) and urine and fill out a short
questionnaire concerning their lifestyle (10 min maximum). Patients will have
minor discomfort and risks will be minimal.
's Gravendijkwal 230
3015 CE Rotterdam
NL
's Gravendijkwal 230
3015 CE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
age >=18
an ALT > 5 x upper limit of normal (ULN) (or AST when ALT is unavailable)
or an ALP > 2 x ULN (especially when associated with 5'-nucleotidase or gamma-glutamyl transpeptidase elevations and when there is no bony cause for rise in ALP)
or an ALT > 3 x ULN plus bilirubin > 2 x ULN
Exclusion criteria
see inclusion criteria
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL29097.078.09 |