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Trial record 53 of 163 for:    ISOTRETINOIN

Single Dose of 9-cis-retinoic Acid in Hepatic Patients

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ClinicalTrials.gov Identifier: NCT01891526
Recruitment Status : Completed
First Posted : July 3, 2013
Last Update Posted : July 3, 2013
Sponsor:
Information provided by (Responsible Party):
Frederik Grønlund MD DMSci, University Hospital, Gentofte, Copenhagen

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.

Condition or disease Intervention/treatment
Hepatic Insufficiency Drug: 9-cis-retinoic acid

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Pharmacokinetics of a Single Dose of 9-cis-retinoic Acid (Alitretinoin, Toctino®) in Patients With Moderate to Severe Hepatic Insufficiency
Study Start Date : December 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Hepatic patients
patients with hepatic insufficiency
Drug: 9-cis-retinoic acid
Single dose of 9-cis-retinoic acid (Capsule 30 mg) as oral exposure

Healthy Controls
Healthy adults
Drug: 9-cis-retinoic acid
Single dose of 9-cis-retinoic acid (Capsule 30 mg) as oral exposure




Primary Outcome Measures :
  1. A comparison of the metabolisation of retinoic acid in patients with hepatic insufficiency and controls [ Time Frame: 24 hours ]
    Analysis on samples


Biospecimen Retention:   Samples Without DNA
Serum and urine


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
10 patients with hepatic disease and 10 controls
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01891526


Locations
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Denmark
Gentofte Hospital
Gentofte, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen

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Responsible Party: Frederik Grønlund MD DMSci, MD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01891526     History of Changes
Other Study ID Numbers: 2010-338
Allitretinoin
First Posted: July 3, 2013    Key Record Dates
Last Update Posted: July 3, 2013
Last Verified: June 2013
Keywords provided by Frederik Grønlund MD DMSci, University Hospital, Gentofte, Copenhagen:
Metabolisation of 9-cis-retinoic acid
hepatic patients
investigation of urine and blood samples
Additional relevant MeSH terms:
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Hepatic Insufficiency
Liver Failure
Liver Diseases
Digestive System Diseases
Tretinoin
Alitretinoin
Isotretinoin
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents