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

Information source: University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatic Insufficiency

Intervention: 9-cis-retinoic acid (Drug)

Phase: N/A

Status: Completed

Sponsored by: University Hospital, Gentofte, Copenhagen


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.

Clinical Details

Official title: The Pharmacokinetics of a Single Dose of 9-cis-retinoic Acid (Alitretinoin, ToctinoŽ) in Patients With Moderate to Severe Hepatic Insufficiency

Study design: Observational Model: Case Control, Time Perspective: Prospective

Primary outcome: A comparison of the metabolisation of retinoic acid in patients with hepatic insufficiency and controls


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


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.

Locations and Contacts

Gentofte Hospital, Gentofte 2900, Denmark
Additional Information

Starting date: December 2010
Last updated: June 28, 2013

Page last updated: August 23, 2015

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