NCT00295360

Brief Summary

The expression of transporters involved in bile acid homeostasis is differentially regulated during obstructive cholestasis. Bile acids are also substrates of the drug efflux transporter breast cancer resistance protein (BCRP) that is highly expressed in the human intestine. Therefore we intend to analyze whether intestinal BCRP expression could be altered during cholestasis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2006

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2006

Completed
Last Updated

February 23, 2006

Status Verified

March 1, 2005

First QC Date

February 17, 2006

Last Update Submit

February 22, 2006

Conditions

Icterus

Keywords

cholestasisBCRPmultidrug resistanceduodenumbile acidsABCG2

Interventions

no intervention, pathophysiological studyBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of obstructive cholestasis (obstructive jaundice was defined on the basis of chemical parameters (bilirubin, g-glutamyltransferase, and alkaline phosphatase) and on imaging procedures (ultrasound and ERCP) demonstrating a dilated bile duct system)
  • control subjects had an indication for a gastrointestinal tract endoscopy within a cancer-screening program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Basel, Department of Research

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

JaundiceCholestasis

Condition Hierarchy (Ancestors)

HyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and SymptomsBile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Jürgen Drewe, MD, MSc

    Department of Clinical Pharmacology, University Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 17, 2006

First Posted

February 23, 2006

Study Start

June 1, 2003

Study Completion

August 1, 2004

Last Updated

February 23, 2006

Record last verified: 2005-03

Locations

CH(1)