- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01891526
Single Dose of 9-cis-retinoic Acid in Hepatic Patients
June 28, 2013 updated by: Frederik Grønlund MD DMSci, University Hospital, Gentofte, Copenhagen
The Pharmacokinetics of a Single Dose of 9-cis-retinoic Acid (Alitretinoin, Toctino®) in Patients With Moderate to Severe Hepatic Insufficiency
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Gentofte, Denmark, 2900
- Gentofte Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
10 patients with hepatic disease and 10 controls
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Hepatic patients
patients with hepatic insufficiency
|
Single dose of 9-cis-retinoic acid (Capsule 30 mg) as oral exposure
|
Healthy Controls
Healthy adults
|
Single dose of 9-cis-retinoic acid (Capsule 30 mg) as oral exposure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A comparison of the metabolisation of retinoic acid in patients with hepatic insufficiency and controls
Time Frame: 24 hours
|
Analysis on samples
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
June 21, 2013
First Submitted That Met QC Criteria
June 28, 2013
First Posted (Estimate)
July 3, 2013
Study Record Updates
Last Update Posted (Estimate)
July 3, 2013
Last Update Submitted That Met QC Criteria
June 28, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010-338
- Allitretinoin
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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