Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2010-12-31
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Hepatic patients
patients with hepatic insufficiency
9-cis-retinoic acid
Single dose of 9-cis-retinoic acid (Capsule 30 mg) as oral exposure
Healthy Controls
Healthy adults
9-cis-retinoic acid
Single dose of 9-cis-retinoic acid (Capsule 30 mg) as oral exposure
Interventions
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9-cis-retinoic acid
Single dose of 9-cis-retinoic acid (Capsule 30 mg) as oral exposure
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
Yes
Sponsors
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University Hospital, Gentofte, Copenhagen
OTHER
Responsible Party
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Frederik Grønlund MD DMSci
MD
Locations
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Gentofte Hospital
Gentofte Municipality, , Denmark
Countries
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Other Identifiers
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Allitretinoin
Identifier Type: -
Identifier Source: secondary_id
2010-338
Identifier Type: -
Identifier Source: org_study_id
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