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

• Sponsor: University Hospital, Gentofte, Copenhagen (Other)
• Overall Status: Completed
• CT.gov ID: NCT01891526
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Duration (Months): 18
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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	Phase
Hepatic Insufficiency	Drug: 9-cis-retinoic acid

Study Design

• 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: Dec 1, 2010
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. A comparison of the metabolisation of retinoic acid in patients with hepatic insufficiency and controls [24 hours]

   Analysis on samples

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gentofte Hospital	Gentofte		Denmark	2900

Sponsors and Collaborators

• University Hospital, Gentofte, Copenhagen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Frederik Grønlund MD DMSci, MD, University Hospital, Gentofte, Copenhagen
• ClinicalTrials.gov Identifier: NCT01891526
• Other Study ID Numbers: 2010-338; Allitretinoin
• First Posted: Jul 3, 2013
• Last Update Posted: Jul 3, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by Frederik Grønlund MD DMSci, MD, University Hospital, Gentofte, Copenhagen: Metabolisation of 9-cis-retinoic acid; hepatic patients; investigation of urine and blood samples
• Additional relevant MeSH terms: Hepatic Insufficiency; Liver Failure; Tretinoin; Alitretinoin; Isotretinoin

Study Results

No Results Posted as of Jul 3, 2013