DRUG
Teduglutide
0.05 mg/kg/day subcutaneously taken once per day for 12 months
A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021
Status
Completed
Phase
Phase 3
Enrollment
14
Locations
5
Results
Posted
Publications
1
Study summary
What the protocol is testing.
This study is a 1-year open label extension study to collect long term efficacy and safety data from patients who have completed approximately 2 years of dosing in Study CL0600-021.
Full detailed description
This study served as a 1-year extension study for those US patients who have completed the CL0600-021 study.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Mar 22, 2012
Study start
May 21, 2012
Primary completion
Jul 23, 2013
Study completion
Jul 23, 2013
Results posted
Dec 25, 2014
Registry updated
Jun 10, 2021
Outcomes
What the study measures.
Primary outcomes
Summary of Treatment-emergent Adverse Events
Time frame · 12 months
As the primary intent of this study was to collect additional safety data, this outcomes measure will provide a summary of the treatment emergent adverse events. Based on the start date of each subject in this study and the study end date, not all subjects reached 12 months.
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * At completion of Study CL0600-021, subjects will be invited to participate in this trial if they meet the following criteria: 1. Completion of the 24-month study, CL0600-021, regardless if fully weaned from PN/I.V. support 2. Signed and dated informed consent form (ICF) to participate before any study-related procedures of Study TED-C11-001 are performed Exclusion Criteria: * None
Study locations
5 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Scripps Clinic & Research Foundation
La Jolla, California, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Mount Sinai Medical Center
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Related trials
More studies on Teduglutide.
NCT IDStudyPhase / statusEnrollmentUpdated
A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome
Takeda · Short Bowel Syndrome
Phase 3
Recruiting
13
2026-06
Glucagon-like Peptide 2 (GLP-2) in Undernourished Women Improving From Histology-Confirmed Environmental Enteric Dysfunction (EED)
International Centre for Diarrhoeal Disease Research, Bangladesh · Environmental Enteric Dysfunction
Phase 2
Not yet recruiting
55
2026-04
A Study of Teduglutide in Japanese People With Short Bowel Syndrome
Takeda · Short Bowel Syndrome
Not applicable
Active, not recruiting
250
2026-04
A Study of Teduglutide in Chinese Children and Teenagers With Short Bowel Syndrome
Takeda · Short Bowel Syndrome (SBS)
Not applicable
Recruiting
12
2026-03
TED_ORG: Study on Short Bowel Syndrome
Meyer Children's Hospital IRCCS · Short Bowel Syndrome (SBS)
Not applicable
Recruiting
50
2026-02
A Survey to Assess Participants' and Physicians' Knowledge When Using GATTEX (Knowledge Assessment Survey)
Takeda · Short Bowel Syndrome (SBS)
Not applicable
Recruiting
600
2026-01
Registry for Participants With Short Bowel Syndrome
Shire · Short Bowel Syndrome
Not applicable
Active, not recruiting
1,806
2025-10
Characterization of the Long-term Safety, Efficacy, and Pharmacodynamics Revestive® in the Management of Short Bowel Syndrome Pediatric Patients
Assistance Publique - Hôpitaux de Paris · Short Bowel Syndrome
Phase 4
Completed
25
2025-09
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.