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A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A One-Year, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition-dependent Short Bowel Syndrome Who Completed Study CL0600-021

NCT01560403•Shire

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (5)

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

Key Dates

Start Date

May 21, 2012

Primary Completion Date

July 23, 2013

Completion Date

July 23, 2013

Last Updated

June 10, 2021

Enrollment

ACTUAL participants

Conditions

Short Bowel Syndrome

Interventions

Teduglutide

DRUG

Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

NCT07197944

Short Bowel Syndrome

View study

RECRUITING

A Survey to Assess Participants' and Physicians' Knowledge When Using GATTEX (Knowledge Assessment Survey)

NCT05561647

Short Bowel Syndrome (SBS)

View study

RECRUITINGPHASE3

A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome

NCT06973304

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 10, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

A Survey to Assess Participants' and Physicians' Knowledge When Using GATTEX (Knowledge Assessment Survey)

A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome

A 90 Day Observational Study as an Extension to the Phase 3,Open Labeled Exploratory Study of RELiZORB

Registry for Participants With Short Bowel Syndrome

Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition