NCT00382486

Brief Summary

The specific aims of this study is to improve short and long-term patient and graft survival, to reduce the incidence and severity of allograft rejection, to reduce the incidence of infection and to reduce and/or eventually eliminate the need for long-term immunosuppression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2001

Typical duration for all trials

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

July 1, 2001

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2006

Completed
Last Updated

December 17, 2007

Status Verified

December 1, 2007

First QC Date

September 28, 2006

Last Update Submit

December 13, 2007

Conditions

Irreversible Intestinal FailureAllograft Rejection

Keywords

Intestinal transplantBone marrowIrradiation of allograft

Interventions

Reduce the risk of allograft rejectionPROCEDURE

Eligibility Criteria

Age17 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all patients between 17 and 70 who are diagnosed with intestinal failure awaiting intestinal/multivisceral transplant

You may not qualify if:

  • active systemic/abdominal infections
  • incurable malignancy
  • acquired immune deficiency syndrome
  • severe cardiopulmonary insufficiency
  • current alcoholism
  • pregnant female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Study Officials

  • Kareem M Abu-Elmagd, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 28, 2006

First Posted

September 29, 2006

Study Start

July 1, 2001

Study Completion

September 1, 2003

Last Updated

December 17, 2007

Record last verified: 2007-12

Locations

US(1)