Single Dose of 9-cis-retinoic Acid in Hepatic Patients
Information source: University Hospital, Gentofte, Copenhagen
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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
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.
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
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
Gentofte Hospital, Gentofte 2900, Denmark
Additional Information
Starting date: December 2010
Last updated: June 28, 2013
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