Hepatic InsufficiencyNCT01891526
Single Dose of 9-cis-retinoic Acid in Hepatic Patients
An observational study of Hepatic Insufficiency, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Insufficiency
- What is being tested?
- 9-cis-retinoic acid
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2010to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 10 patients with hepatic disease and 10 controls
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- Stroke
- Esophagal bleeding
- Severe ascites
- HIV-positivity
- Psychiatric disorder
- Cancer
- pregnancy or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hepatic Insufficiency
- Being tested
- 9-cis-retinoic acid
- Keywords
- Metabolisation of 9-cis-retinoic acid, hepatic patients, investigation of urine and blood samples
- Medical subject headings
- Hepatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9-cis-retinoic acidDrug
Single dose of 9-cis-retinoic acid (Capsule 30 mg) as oral exposure
| Study group | Role | What they receive |
|---|---|---|
| Hepatic patients | patients with hepatic insufficiency Receives: Drug: 9-cis-retinoic acid | |
| Healthy Controls | Healthy adults Receives: Drug: 9-cis-retinoic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
A comparison of the metabolisation of retinoic acid in patients with hepatic insufficiency and controls
Analysis on samples
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startDec 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederik Grønlund MD DMSci, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891526
- Sponsor's protocol ID
- 2010-338
- Other IDs
- Allitretinoin
- Status last verified
- Jun 2013
- First submitted
- 21 Jun 2013
- Last updated
- 3 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetics of a Single Dose of 9-cis-retinoic Acid (Alitretinoin, Toctino®) in Patients With Moderate to Severe Hepatic Insufficiency
- ClinicalTrials.gov ID
- NCT01891526
- Acronym / sponsor ID
- 2010-338
- Conditions
- Hepatic Insufficiency
- Keywords
- Metabolisation of 9-cis-retinoic acid, hepatic patients, investigation of urine and blood samples
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 3 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hepatic patients | – | Drug: 9-cis-retinoic acidpatients with hepatic insufficiency |
| Healthy Controls | – | Drug: 9-cis-retinoic acidHealthy adults |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 10 patients with hepatic disease and 10 controls
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 9-cis-retinoic acidSingle dose of 9-cis-retinoic acid (Capsule 30 mg) as oral exposure | Drug | Healthy Controls, Hepatic patients |
Primary outcome
A comparison of the metabolisation of retinoic acid in patients with hepatic insufficiency and controls
Time frame: 24 hours
Analysis on samples
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Insufficiency, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A comparison of the metabolisation of retinoic acid in patients with hepatic insufficiency and controls (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2013.