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OpenTrials
Completed

NCT Number: NCT01891526

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

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.

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Key information

Conditions

Hepatic Insufficiency Digestive System Diseases Liver Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gentofte Hospital

Gentofte Municipality, 2900, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

9-cis-Retinoic Acid

Drug

Single dose of 9-cis-retinoic acid (Capsule 30 mg) as oral exposure

Primary outcomes

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

    Time frame: 24 hours

    Analysis on samples

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Official study title

The Pharmacokinetics of a Single Dose of 9-cis-retinoic Acid (Alitretinoin, Toctino®) in Patients With Moderate to Severe Hepatic Insufficiency

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 3, 2013
Registry last updated
Jul 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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