Hepatic Insufficiency
Conditions
Keywords
Metabolisation of 9-cis-retinoic acid, hepatic patients, investigation of urine and blood samples
Brief summary
To test whether patients with hepatic insufficiency can tolerate one oral dose of 9-cis-retinoic acid and to test whether the metabolism of retinoic acid is altered.
Interventions
Single dose of 9-cis-retinoic acid (Capsule 30 mg) as oral exposure
Sponsors
University Hospital, Gentofte, Copenhagen
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Have biopsy verified hepatic insufficiency 2. Medically stable. 3. Ultra sonic examination of lever within the past 3 months 4. No pregnancy documented in women. use of anticonception during study and 1 month after
Exclusion criteria
1. Odd blood counts and samples not related to hepatic disease 2. encephalopathy (\> grad II) 3. concomitant treatment with pharmaca that is metabolized by CYP3A4 in the liver. 4. Cardiac disease 5. Kidney disease 6. Epilepsia 7. Stroke 8. Esophagal bleeding 9. Severe ascites 10. HIV-positivity 11. Psychiatric disorder 12. Cancer 13. pregnancy or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A comparison of the metabolisation of retinoic acid in patients with hepatic insufficiency and controls | 24 hours | Analysis on samples |
Countries
Denmark
Outcome results
None listed