Status:
COMPLETED
Pharmacokinetics of 9-cis-retinoic Acid (Alitretinoin, Toctino®) in Patients With Hepatic Disease
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Conditions:
Hepatic Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study aims to investigate whether liver patients may tolerate alitretinoin by comparing metabolism in 8 such patients with the metabolism in 8 healthy controls
Detailed Description
This study aims to investigate whether liver patients may tolerate alitretinoin. Toctino (alitretinoin) is a vitamin A like substance that has proven effective in the treatment of specially hand ecze...
Eligibility Criteria
Inclusion
- Be medically stable for at least 1 month before the intake of 9-cis-RA.
- There must be an ultrasound scan of liver and abdomen within the last 3 months (liver size, ascites).
- In women of childbearing age, there must be a negative pregnancy test, while that to be used adequate contraception (the pill, coil or surgical sterilization) at least 1 month after taking the study medication.
Exclusion
- Clinically significant deviations in routine blood tests (hematology, electrolytes and kid-ney, urinalysis). Differences attributable to underlying liver disease are excluded.
- Encephalopathy (\> grade II)
- Concomitant treatment with drugs predominantly metabolised in the liver by CYP3A4.
- Clinically significant ECG changes, cardiovascular disease and AMI within the last 12 months
- Affected renal function judged by Cockcroft-Gault formula.
- Epilepsy or significant neurological disease that requires drug therapy.
- History of cerebrovascular relapse
- Esophagus bleeding
- Severe ascites
- HIV
- Mental illness.
- Active cancer
- Pregnancy or pregnancy plan within 3 months.
- Breastfeeding women.
- Participation in other clinical projects.
- Intake of clinical trial medication in the past month.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01261923
Start Date
December 1 2010
End Date
August 1 2011
Last Update
January 29 2013
Active Locations (1)
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1
Gentofte Hospital
Hellerup, Denmark, 2900