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

Completed

• Conditions: Hepatic Insufficiency
• Interventions: Drug: 9-cis-retinoic acid

• Registration Number: NCT01891526
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-06
• Study First Submitted: 2013-06-21
• Study First Submitted QC: 2013-06-28
• Last Update Submitted: 2013-06-28
• Study First Posted: 2013-07-03
• Last Update Posted: 2013-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Controls	9-cis-retinoic acid	Healthy adults
Hepatic patients	9-cis-retinoic acid	patients with hepatic insufficiency

Primary Outcome Measures

Name	Time	Method
A comparison of the metabolisation of retinoic acid in patients with hepatic insufficiency and controls	24 hours	Analysis on samples

Trial Locations

Locations (1)

Gentofte Hospital; 🇩🇰 Gentofte, Denmark