Measurement of MRP2 Function Using Urinary Coproporphyrins | NCT00746044

Studies
Measurement of MRP2 Function Using Urinary Coproporphyrins

NCT00746044

Sponsor

University Hospital, Tours

Status

Completed

Last Update Posted

May 15, 2009Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

Healthy Subjects

Interventions

Not provided

Countries

France

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

Status Module

Record Verification Date

May 2009

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

Feb 2008

Primary Completion Date

Apr 2008Actual

Completion Date

Apr 2009Actual

First Submitted Date

Sep 1, 2008

First Submission Date that Met QC Criteria

Sep 1, 2008

First Posted Date

Sep 3, 2008Estimated

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

May 14, 2009

Last Update Posted Date

May 15, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Human Multidrug Related Protein 2 (MRP2) excretes several drugs and could therefore modulate their elimination. Individual's MRP2 activity is under genetic control. Thus it would be very useful to get an easily measurable biomarker reflecting individual's MRP2 activity. We aimed to investigate the ratio of urinary coproporphyrins I and III (UCP(I/I+III), known to be increased in patients with mutations in MRP2/ABCC2 gene.

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

40Actual

Label	Type	Description	Intervention Names
1		Healthy volunteers >18y, 20 male, 20 female

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Urinary coproporphyrins (I/I+III)ratio		End of three 24-hours periods

Secondary Outcomes

Measure	Description	Time Frame
ABCC2 polymorphisms		At the time of entering in the study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy
> 18 y
Affiliated to an health insurance

Exclusion Criteria:

Patient not able to understand or to comply to the protocol

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

40 healthy subjects > 18 y 20 male, 20 female

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chantal LE GUELLEC	CHRU TOURS	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de TOURS		Tours		37000	France