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

University Hospital, Gentofte, Copenhagen

Status: Completed

Conditions: Hepatic Insufficiency

Treatments: Drug: 9-cis-retinoic acid

Study type: Observational

Funder types: Other

Identifiers

NCT01891526

Allitretinoin

2010-338

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

20 participants in 2 patient groups

Hepatic patients

Description:

patients with hepatic insufficiency

Treatment:

Drug: 9-cis-retinoic acid

Healthy Controls

Description:

Healthy adults

Treatment:

Drug: 9-cis-retinoic acid