A Study in Japanese Children With Short Bowel Syndrome Who Completed SHP633-302

What Was Tested

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

The purpose of this clinical study is to evaluate the long-term safety and tolerability of teduglutide treatment in Japanese pediatric participants with short bowel syndrome (SBS) who completed Study SHP633-302 (NCT02980666).

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

The registry classes the interventions as drug.

Who Took Part

9 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: 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 \[IRB\]) by the participant prior to any study-related procedures. Participant completed Study SHP633-302 (NCT02980666). Participant (and/or parent/guardian) understands and is willing and able to fully adhere to study requirements as defined in this protocol.

The full record lists 4 inclusion and 0 exclusion criteria.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Teduglutide (GLP-2 analog) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2017-08-23 with completion listed for 2021-11-02.

It ran at 6 sites in Japan (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: From Baseline up to follow-up (up to 50 months)). Percent Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment (time frame: Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)). Percent Change From Baseline in Average Number of Stools Per Day at EOT of Last Cycle During Teduglutide Treatment (time frame: Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks)).

It also tracked 9 secondary outcomes, for example Change From Baseline in Participant Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment, Percent Change From Baseline in Participant Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment, Change From Baseline in Investigator Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment, Percent Change From Baseline in Investigator Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment, Number of Participants Who Achieved Enteral Autonomy PS Volume at EOT of Each Cycle During Teduglutide Treatment and Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Teduglutide (GLP-2 analog) in 9 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.