Skip to content

Genetic risk factors for hepatotoxicity during anti tuberculosis treatment.

Genetic risk factors for hepatotoxicity during anti tuberculosis treatment. - HEPTB

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON29714
Enrollment
325
Registered
2006-08-11
Start date
2006-07-01
Completion date
Unknown
Last updated
2024-06-18

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

Conditions

leverbijwerkingen van standaard tuberculosebehandeling hepatotoxicity liver side effects

Interventions

None listed

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patient is treated for tuberculosis (pulmonary or extra-pulmonary) with standard treatment containing at least isoniazid, rifampicin and pyrazinamide. - Age: above 18 years.

Exclusion criteria

Exclusion criteria: - Patient receives treatment for multi-drug resistant tuberculosis. - Patient also receives antiretroviral treatment and developed liver function disorders immediately after the start of ART.

Design outcomes

Primary

MeasureTime frame
Association between ATDH and genetic polymorphisms (single nucleotide polymorphisms) in drug metabolising enzymes and regulators of enzyme expression. Enzymes: N-acetyltransferase 2, glutathione S-transferase, cytochrome P450 2E1. Receptors: pregnane X-receptor (PXR), multidrug resistance gene 1 (MDR1).

Secondary

MeasureTime frame
Association between ATDH and other risk factors, including age, sex, weight and length, underlying liver disease and HIV-status.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)