NCT04916665

Brief Summary

In this case report the investigators present a novel strategy for using teduglutide as a bridging therapy to intestinal reconstruction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 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

January 1, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
Last Updated

June 7, 2021

Status Verified

June 1, 2021

Enrollment Period

12 months

First QC Date

May 30, 2021

Last Update Submit

June 3, 2021

Conditions

Short Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

  • enteral autonomy (complete discontinuation of parenteral support)

    observe if enteral autonomy may be achieved before reconstruction

    6 months

Interventions

TeduglutideDRUG

bridging intestinal failure with teduglutide until reconstruction

Eligibility Criteria

Sexmale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

case report

You may qualify if:

  • short bowel syndrome

You may not qualify if:

  • \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Austria

Location

MeSH Terms

Conditions

Short Bowel Syndrome

Interventions

teduglutide

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator, M.D.

Study Record Dates

First Submitted

May 30, 2021

First Posted

June 7, 2021

Study Start

January 1, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

June 7, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)