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

Phase 3

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
teduglutide	teduglutide	0.05 mg/kg/day

Primary Outcome Measures

Name	Time	Method
Percent Change in PN/IV Volume by Visit	24 months	The mean change from baseline in weekly PN.IV volume in percent change is shown by visit.
Absolute Change in PN/IV Volume by Visit	24 months	The mean change from baseline in weekly PN.IV volume in Liters is shown by visit.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Achieving PN/IV Reduction	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.

Locations (23): Scripps Clinic & Research Foundation
🇺🇸
La Jolla, California, United States
Mount Sinai Medical Center
🇺🇸
New York, New York, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
University of Pennslyvania
🇺🇸
Philadelphia, Pennsylvania, United States
University Of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States
Royal Alexandra Hospital
🇨🇦
Edmonton, Alberta, Canada
St. Michael's Hospital
🇨🇦
Toronto, Ontario, Canada
University Health Network - Toronto General Hospital
🇨🇦
Toronto, Ontario, Canada
Rigshospitalet
🇩🇰
København, Denmark
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Scripps Clinic & Research Foundation
🇺🇸La Jolla, California, United States