Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 Study

What Was Tested

The trial (phase 3) is built around Teduglutide (GLP-2 analog).

It will evaluate how these children fared after the TED-C13-003 study ended.

This study will also offer teduglutide treatment to eligible subjects, regardless of treatment received in TED-C13-003.

It had 1 arm (groups): Standard of Care (SOC) Treatment +/- Teduglutide (experimental).

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 29 actual participants took part.

It was open to people of any sex.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Subject provides written informed consent (subject, parent or legal guardian and, as appropriate, subject informed assent) to participate in the study before completing any study-related procedures. Subject completed the TED-C13-003 study (including subjects in the standard of care treatment arm). Subject understands and is willing and able to fully adhere to study requirements as defined in this protocol.

The full record lists 3 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Teduglutide (GLP-2 analog) study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2016-12-09 with completion listed for 2020-07-14.

It ran at 11 sites in United States (10) and United Kingdom (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants With Adverse Events (AEs) in Retrospective Observation Period (time frame: From end of the core study (TED-C13-003 [NCT01952080]) up to the beginning of the prospective period (up to Week 168)). Change From Baseline in Height for Age Z-score up to Week 168 of Retrospective Observation Period. Change From Baseline in Body Weight for Age Z-score up to Week 168 of Retrospective Observation Period.

It also tracked 19 secondary outcomes, for example Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period, Percent Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period, Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period, Percent Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period, Change From Baseline in Number of Hours Per Day of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period and Percent Change From Baseline in Number of Hours Per Day of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Teduglutide (GLP-2 analog) in 29 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Teduglutide (GLP-2 analog) compound page, all human trials.