Single Dose of 9-cis-retinoic Acid in Hepatic Patients | NCT01891526

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

NCT01891526

Sponsor

University Hospital, Gentofte, Copenhagen

Status

Completed

Last Update Posted

Jul 3, 2013Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Hepatic Insufficiency

Interventions

9-cis-retinoic acid

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Allitretinoin

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Jun 21, 2013

First Submission Date that Met QC Criteria

Jun 28, 2013

First Posted Date

Jul 3, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2013

Last Update Posted Date

Jul 3, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Frederik Grønlund MD DMSci, MD, University Hospital, Gentofte, CopenhagenPrincipal Investigator

Lead Sponsor

University Hospital, Gentofte, CopenhagenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hepatic patients		patients with hepatic insufficiency	Drug: 9-cis-retinoic acid
Healthy Controls		Healthy adults	Drug: 9-cis-retinoic acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
9-cis-retinoic acid	Drug	Single dose of 9-cis-retinoic acid (Capsule 30 mg) as oral exposure	Healthy Controls Hepatic patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

10 patients with hepatic disease and 10 controls

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gentofte Hospital		Gentofte Municipality		2900	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D048550	Hepatic Insufficiency

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077556	Alitretinoin

Ancestor Terms

ID	Term
D014212	Tretinoin
D014801	Vitamin A
D012176	Retinoids
D002338	Carotenoids
D011090

Browse Leaves

Not provided

Browse Branches

Not provided