Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)

June 3, 2021 updated by: Shire

A Long-Term, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition Dependent Short Bowel Syndrome

This study is a 2-year open label extension study to collect long term efficacy and safety data from patients who have completed the 24-weeks of study drug dosing in CL0600-020.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Some people with SBS need to infuse parenteral nutrition (PN) in order to live. Although PN can save lives, it can lead to some serious side effects such as infection or liver damage. The risk for those effects increases the longer people are on PN.

Teduglutide is an investigative medicine being evaluated as a possible treatment for people with PN-dependent SBS. Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. We want to see if teduglutide can help decrease the amount of PN needed because the body is doing a better job of taking up what it eats and drinks. We also want to find out how safe teduglutide is and record any side effects.

Study Type

Interventional

Enrollment (Actual)

88

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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5H 4B9
        • Royal Alexandra Hospital
    • Ontario
      • Toronto, Ontario, Canada, M5G 2N2
        • University Health Network - Toronto General Hospital
      • Toronto, Ontario, Canada, M5B1W8
        • St. Michael's Hospital
  • Denmark
      • København, Denmark, 2100
        • Rigshospitalet
  • France
      • Clichy, France
        • Hôpital Beaujon
      • Nice, France
        • Hopital de l'Archet 2
  • Germany
    • BE
      • Berlin, BE, Germany, 13353
        • Med. Klinik m.S. Hepatologie und Gastroenterologie
    • BW
      • Tuebingen, BW, Germany, 72076
        • Universitaetsklinikum Tuebingen Medizinische Klinik I
  • Italy
      • Napoli, Italy, 80131
        • Azienda Universitaria Policlinico Federico II
  • Poland
      • Lodz, Poland, 90-531
        • Wojewodzki Szpital Specjalistyczny im. M. Pirogowa, Pracownia Leczenia Zywieniowego
      • Lublin, Poland, 20-090
        • Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Chirurgii Ogolnej i Transplantacyjnej
      • Olsztyn, Poland, 10-651
        • Pracownia Żywienia Klinicznego
      • Warsaw, Poland, 00-416
        • Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP
  • Spain
      • Barcelona, Spain, 08907
        • Hospital Universitario de Bellvitge
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
  • United Kingdom
      • Harrow, United Kingdom, HA13UJ
        • St. Marks Hospital
      • London, United Kingdom, WC1E 6DB
        • University College London Hospital
  • United States
    • California
      • La Jolla, California, United States, 92037
        • Scripps Clinic & Research Foundation
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennslyvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

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:

  • must have completed 24 weeks of dosing of the CL0600-020 study

Exclusion Criteria:

  • none

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: teduglutide
0.05 mg/kg/day
Drug: teduglutide
0.05 mg/kg/day subcutaneously taken once per day for 24 months
Other Names:
  • Gattex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in PN/IV Volume by Visit
Time Frame: 24 months
The mean change from baseline in weekly PN.IV volume in percent change is shown by visit.
24 months
Absolute Change in PN/IV Volume by Visit
Time Frame: 24 months
The mean change from baseline in weekly PN.IV volume in Liters is shown by visit.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Achieving PN/IV Reduction
Time Frame: 24 Months or Last Dosing Visit
The number of subjects who achieve at least 1-, 2-, and 3-day reductions in PN/IV per Week.
24 Months or Last Dosing Visit

Collaborators and Investigators

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

Sponsor

Shire

Collaborators

Nycomed Germany GmbH

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)

September 21, 2009

Primary Completion (Actual)

January 24, 2013

Study Completion (Actual)

January 24, 2013

Study Registration Dates

First Submitted

June 26, 2009

First Submitted That Met QC Criteria

June 29, 2009

First Posted (Estimate)

June 30, 2009

Study Record Updates

Last Update Posted (Actual)

June 11, 2021

Last Update Submitted That Met QC Criteria

June 3, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL0600-021
  • 2009-011679-65 (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.

Clinical Trials on Short Bowel Syndrome

Clinical Trials on teduglutide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe