NCT00179439

Brief Summary

The investigators hypothesize that PSC in children is associated with mutations and functional changes of the cystic fibrosis (CF) gene.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2004

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

December 13, 2017

Status Verified

December 1, 2017

Enrollment Period

2 years

First QC Date

September 12, 2005

Last Update Submit

December 11, 2017

Conditions

Primary Sclerosing CholangitisInflammatory Bowel Disease

Keywords

PSCIBDCFTR

Outcome Measures

Primary Outcomes (1)

  • CFTR DNA analysis

Secondary Outcomes (2)

  • Nasal potential difference testing

  • Sweat test

Interventions

nasal potential difference testingPROCEDURE

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • years of age and older
  • Must have diagnosis of primary sclerosing cholangitis and/or inflammatory bowel disease
  • Absence of other liver disease, such as viral hepatitis, drug-induced liver disease, and metabolic/hereditary liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Cholangitis, SclerosingInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

CholangitisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal Diseases

Study Officials

  • Harpreet Pall, MD

    Boston Children's Hospital

    STUDY DIRECTOR

  • Steven D Freedman, MD, PhD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD Full Professor Harvard Medical School

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

January 1, 2004

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

December 13, 2017

Record last verified: 2017-12

Locations

US(1)