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Clinical Trials/NCT01560403
NCT01560403
Completed
Phase 3

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

Shire5 sites in 1 country14 target enrollmentMay 21, 2012
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ConditionsShort Bowel Syndrome
InterventionsTeduglutide
DrugsTeduglutide

Overview

Phase
Phase 3
Intervention
Teduglutide
Conditions
Short Bowel Syndrome
Sponsor
Shire
Enrollment
14
Locations
5
Primary Endpoint
Summary of Treatment-emergent Adverse Events
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 21, 2012
End Date
July 23, 2013
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Shire
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •At completion of Study CL0600-021, subjects will be invited to participate in this trial if they meet the following criteria:
  • •Completion of the 24-month study, CL0600-021, regardless if fully weaned from PN/I.V. support
  • •Signed and dated informed consent form (ICF) to participate before any study-related procedures of Study TED-C11-001 are performed

Exclusion Criteria

  • Not provided

Arms & Interventions

Teduglutide

0.05 mg/kg/day

Intervention: Teduglutide

Outcomes

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.

Study Sites (5)

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