Status:
COMPLETED
Single Dose of 9-cis-retinoic Acid in Hepatic Patients
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Conditions:
Hepatic Insufficiency
Eligibility:
All Genders
18-70 years
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.
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Have biopsy verified hepatic insufficiency
- Medically stable.
- Ultra sonic examination of lever within the past 3 months
- No pregnancy documented in women. use of anticonception during study and 1 month after
- Exclusion criteria:
- Odd blood counts and samples not related to hepatic disease
- encephalopathy (\> grad II)
- concomitant treatment with pharmaca that is metabolized by CYP3A4 in the liver.
- Cardiac disease
- Kidney disease
- Epilepsia
- Stroke
- Esophagal bleeding
- Severe ascites
- HIV-positivity
- Psychiatric disorder
- Cancer
- pregnancy or lactating women.
Exclusion
Key Trial Info
Start Date :
December 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01891526
Start Date
December 1 2010
End Date
June 1 2012
Last Update
July 3 2013
Active Locations (1)
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1
Gentofte Hospital
Gentofte Municipality, Denmark, 2900