This study is currently not recruiting participants.

A Prospective Open-label Long-term Safety and Efficacy Study of Teduglutide in Pediatric Patients with Short Bowel Syndrome Who Completed TED-C14-006

Investigating the Safety and Effects of an Investigational Medication in Children with Short Bowel Syndrome

Not Recruiting
100 years or below
All
Phase N/A
1 Location

Brief description of study.

The purpose of this study is to answer the following questions: How safe is teduglutide in children with SBS over a long-term period? Can teduglutide help children with SBS decrease the amount of PS they need, and to decrease the time they are connected to an IV pump, over a long-term period? How long do children with SBS need to take teduglutide?

Detailed description of study

The purpose of this study is to answer the following questions: How safe is teduglutide in children with SBS over a long-term period? Can teduglutide help children with SBS decrease the amount of PS they need, and to decrease the time they are connected to an IV pump, over a long-term period? How long do children with SBS need to take teduglutide?

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: short bowel syndrome
  • Age: 100 years or below
  • Gender: All

This study investigates the safety of an investigational medication in children with Short Bowel Syndrome (SBS) over a long-term period. Short Bowel Syndrome is a condition where nutrients are not absorbed properly due to a lack of sufficient small intestine. The study aims to see if this medication can help reduce the amount of parenteral support (PS) needed by these children, which is nutrition given through an IV.

Participants will receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will monitor how the medication affects the amount of time children need to be connected to an IV pump and how much PS they require.

  • Who can participate: This study is looking for children diagnosed with Short Bowel Syndrome, aged 2 to 17 years. Participants must require parenteral support and be connected to an IV pump regularly.
  • Study details: Participants will be randomly assigned to receive either the investigational medication or a placebo.
Updated on 19 Feb 2024. Study ID: 1610856659

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