Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)

May 12, 2021 updated by: Shire

A Study of the Safety and Efficacy of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)

The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Teduglutide is an analog of naturally occurring human glucagon-like peptide-2 (GLP-2), a peptide secreted by L-cells of the distal intestine. GLP-2 is known to increase intestinal and portal blood flow, and inhibit gastric acid secretion. Teduglutide binds to the glucagon-like peptide-2 receptors located in intestinal subpopulations of enteroendocrine cells, subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric plexus. Activation of these receptors results in the local release of multiple mediators including insulin-like growth factor (IGF)-1, nitric oxide and keratinocyte growth factor (KGF).

This multicenter, double-blind, international, Phase III trial will have a treatment period of 28 weeks. Subjects in this study are those who received teduglutide or placebo in protocol CL0600-004 (NCT00081458). These subjects will receive daily subcutaneous injections of 0.05 milligrams or 0.10 milligrams of teduglutide per kilogram of body weight. Subjects will have visits every 4 to 6 weeks and will be assessed for parenteral nutrition (PN) reduction with a follow-up period of 4 weeks duration for those subjects who do not complete this protocol, or do not enter into the long-term safety extension protocol CL0600-010.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Hôpital Erasme
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z1Y6
        • St. Paul's Hospital
    • Ontario
      • Toronto, Ontario, Canada, M5B1W8
        • St. Michael's Hospital
      • Toronto, Ontario, Canada, M5G2N2
        • Toronto General Hospital
  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
  • France
      • Lille, France, 59037
        • Hôpital Huriez
      • Lyon, France, 69317
        • Hopital De La Croix-Rousse
      • Paris, France, 92110
        • Hôpital Lariboisière
  • Netherlands
      • Amsterdam, Netherlands, 1100 DD
        • Academic Medical Center, Department of Endocrinology & Metabolism
  • Poland
      • Olsztyn, Poland, 10-561
        • Pracownia Żywienia
      • Warsaw, Poland, 00-416
        • Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP
  • United Kingdom
      • Harrow, United Kingdom, HAI3UJ
        • St. Mark's Hospital
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic Scottsdale
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania - Penn Nursing
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

At dosing week 24 of protocol CL0600-004 (NCT00081458), subjects will be reviewed for their participation in this study.

Subjects who meet all of the following criteria can be enrolled in this study:

  • Signed and dated informed consent form (ICF) to participate before any study-related procedures are performed
  • Completion of protocol CL0600-004 (NCT00081458)

Exclusion Criteria:

  • History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state
  • History of alcohol or drug abuse (within previous year)
  • Prior use of native glucagon-like peptide 2 (GLP-2) within 3 months of screening visit
  • Pregnant or lactating women
  • Any condition or circumstance, which in the investigator's opinion would put the subject at any undue risk, prevent completion of the study, or interfere with analysis of the study results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: teduglutide 0.05 mg/kg/d
0.05 mg/kg/d teduglutide subcutaneous injection
Drug: teduglutide 0.05 mg/kg/d
0.05 mg/kg/d subcutaneous injection
Other Names:
  • GATTEX
Experimental: teduglutide 0.10 mg/kg/d
0.10 mg/kg/d teduglutide subcutaneous injection
Drug: teduglutide 0.10 mg/kg/d
0.10 mg/kg/d subcutaneous injection
Other Names:
  • GATTEX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Achieving a 20% Reduction at Week 28
Time Frame: 28 weeks
For those subjects who received teduglutide (0.05 or 0.10 mg dose) in Study 004 and the same in Study 005, Parenteral Nutrition (PN) Use at Week 28 was compared to the Baseline Visit of Study 004 to calculate the 20% reduction in PN Use. For those subjects who received placebo in Study 004 and either teduglutide 0.05 or 0.10 mg dose in Study 005, PN Use at Week 28 was compared to the use of PN at Week 24 of Study 004 to calculate the 20% reduction in PN Use.
28 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use
Time Frame: 6 months
Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use (Responder Status is Yes or No)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2005

Primary Completion (Actual)

January 24, 2008

Study Completion (Actual)

January 24, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Actual)

June 2, 2021

Last Update Submitted That Met QC Criteria

May 12, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL0600-005
  • 2004-000439-27 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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