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OpenTrials
Completed

NCT Number: NCT00930644

Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)

This study is a 2-year open label extension study to collect long term efficacy and safety data from patients who have completed the 24-weeks of study drug dosing in CL0600-020.

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Key information

Conditions

Short Bowel Syndrome Digestive System Diseases Gastrointestinal Diseases Hyperphagia Intestinal Diseases Malabsorption Syndromes Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal Alexandra Hospital, Edmonton, Alberta, Canada

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About this study

Some people with SBS need to infuse parenteral nutrition (PN) in order to live. Although PN can save lives, it can lead to some serious side effects such as infection or liver damage. The risk for those effects increases the longer people are on PN.

Teduglutide is an investigative medicine being evaluated as a possible treatment for people with PN-dependent SBS. Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. We want to see if teduglutide can help decrease the amount of PN needed because the body is doing a better job of taking up what it eats and drinks. We also want to find out how safe teduglutide is and record any side effects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • must have completed 24 weeks of dosing of the CL0600-020 study

Exclusion criteria

  • none

Treatment and study plan

Teduglutide

Drug

0.05 mg/kg/day subcutaneously taken once per day for 24 months

Other names: Gattex

Primary outcomes

  1. Percent Change in PN/IV Volume by Visit

    Time frame: 24 months

    The mean change from baseline in weekly PN.IV volume in percent change is shown by visit.

  2. Absolute Change in PN/IV Volume by Visit

    Time frame: 24 months

    The mean change from baseline in weekly PN.IV volume in Liters is shown by visit.

Secondary outcomes

  1. Number of Subjects Achieving PN/IV Reduction

    Time frame: 24 Months or Last Dosing Visit

    The number of subjects who achieve at least 1-, 2-, and 3-day reductions in PN/IV per Week.

Sponsors and collaborators

Lead sponsor

Shire

Industry

Collaborators

  • Nycomed Germany GmbH

Registry information

Official study title

A Long-Term, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition Dependent Short Bowel Syndrome

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jun 30, 2009
Registry last updated
Jun 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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