Single Dose of 9-cis-retinoic Acid in Hepatic Patients

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Gentofte, Copenhagen
• Treatments: Alitretinoin; Isotretinoin; Tretinoin

Criteria

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.