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

Phase 3

Completed

• Conditions: Short Bowel Syndrome
• Interventions: Drug: Teduglutide

• Registration Number: NCT01560403
• Lead Sponsor: Shire

Brief 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.

Study Timeline

• Study First Submitted: 2012-03-13
• Study First Submitted QC: 2012-03-20
• Study First Posted: 2012-03-22
• Study Start: 2012-05-21
• Primary Completion: 2013-07-23
• Study Completion: 2013-07-23
• Results First Submitted: 2014-12-16
• Results First Submitted QC: 2014-12-24
• Results First Posted: 2014-12-25
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-26
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Teduglutide	Teduglutide	0.05 mg/kg/day

Primary Outcome Measures

Name	Time	Method
Summary of Treatment-emergent Adverse Events	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.

Trial Locations

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

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States