A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome

What Was Tested

This registered phase 3 trial tested Teduglutide (GLP-2 analog).

This will be an open label, 4-cohort study.

Non-randomized subjects will receive teduglutide in each of the 3 active cohorts.

An attempt will be made to enroll additional subjects into an observational cohort who will receive standard of care.

It had two arms (groups): teduglutide (experimental) and Standard of Care (no intervention).

Open label teduglutide, subcutaneously injected.

The registry classes the interventions as drug.

Who Took Part

The registry lists 42 actual participants took part.

It was open to people of any sex aged from 1 Year up to 17 years.

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

Examples of who could join: Current history of SBS as a result of major intestinal resection, (eg, due to necrotizing enterocolitis, midgut volvulus, intestinal atresia, or gastroschisis) for at least 12 months prior to screening. Short bowel syndrome that requires parenteral nutrition/intravenous (PN/IV) support. Stable PN/IV support for at least 3 months prior to enrollment based upon the opinion of the investigator.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: serial transverse enteroplasty or any other bowel lengthening procedure performed within the past 3 months; unstable absorption due to cystic fibrosis, untreated hirschsprung's disease or known dna abnormalities (ie, familial adenomatous polyposis, fanconi syndrome); evidence of obstruction on upper gastrointestinal (gi) series done within 6 months prior to screening.

How the Study Was Run

It was run as a non-randomized, single-group and open-label study.

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 2013-11-14 with completion listed for 2015-01-09.

It ran at 19 sites in United States (18) and United Kingdom (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percent Change in Parenteral Support [Parenteral Nutrition (PN)/Intravenous (IV)] Volume at Week 12 (time frame: Baseline, Week 12). Percent Change in Parenteral Support (PN/IV) Volume at End of Treatment (time frame: Baseline, End of Treatment). Percent Change in Parenteral Support (PN/IV) Volume at Week 16 (time frame: Baseline, Week 16).

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Teduglutide (GLP-2 analog) in 42 people.

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.