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Pharmacogenetics of drug-induced liver injury

Pharmacogenetics of drug-induced liver injury - DILI

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON38286
Enrollment
325
Registered
2010-02-19
Start date
2011-02-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

drug-induced liver injury

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: see inclusion criteria

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
None

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)