Study in Japanese Pediatric Subjects With Short Bowel Syndrome (SBS) Who Are Dependent on Parenteral Support

What Was Tested

In this phase 3 trial, researchers set out to test Teduglutide (GLP-2 analog).

It had 1 arm (groups): Teduglutide (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 10 actual participants took part.

It was open to people of any sex aged from 4 months up to 15 years.

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

Examples of who could join: Informed consent by a parent or guardian prior to any study-related procedures. When applicable, informed assent (as deemed appropriate by the Institutional Review Board) by the participant prior to any study-related procedures. Male or female infant 4 to \<12 months corrected gestational age or child or adolescent aged 1 year through 15 years. Current history of SBS as a result of major intestinal resection (eg, due to necrotizing enterocolitis, midgut volvulus, intestinal atresia, or gastroschisis). Stable PN/IV support, defined as:.

The full record lists 6 inclusion and 32 exclusion criteria; among the exclusions: participants who are not expected to be able to advance oral or tube feeding regimens; serial transverse enteroplasty or any other bowel lengthening procedure performed within 3 months of screening; unstable absorption due to cystic fibrosis or other known dna abnormalities (eg, familial adenomatous polyposis, fanconi-bickel syndrome).

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 2017-01-13 with completion listed for 2020-01-21.

It ran at 5 sites in Japan (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Absolute Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) Based on Dairy Data (time frame: Baseline, EOT (up to Week 24)). Percent Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) Based on Dairy Data (time frame: Baseline, EOT (up to Week 24)). Absolute Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) Based on Dairy Data (time frame: Baseline, EOT (up to Week 24)).

What This Means in Plain Language

Put simply, this is a phase 3 trial of Teduglutide (GLP-2 analog) in 10 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.