A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021

What Was Tested

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

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

The registry classes the interventions as drug.

More on the Plan

This study served as a 1-year extension study for those US patients who have completed the CL0600-021 study.

Who Took Part

The registry lists 14 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: At completion of Study CL0600-021, subjects will be invited to participate in this trial if they meet the following criteria:. Completion of the 24-month study, CL0600-021, regardless if fully weaned from PN/I.V. support. Signed and dated informed consent form (ICF) to participate before any study-related procedures of Study TED-C11-001 are performed.

The full record lists 3 inclusion and 1 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 2012-05-21 with completion listed for 2013-07-23.

It ran at 5 sites in United States (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Summary of Treatment-emergent Adverse Events (time frame: 12 months).

What This Means in Plain Language

Put simply, this is a phase 3 trial of Teduglutide (GLP-2 analog) in 14 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.