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

Primary Purpose

Short Bowel Syndrome

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
teduglutide
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Short Bowel Syndrome focused on measuring short bowel syndrome, parenteral nutrition, PN, HPN, TPN, SBS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Sites / Locations

  • Scripps Clinic & Research Foundation
  • Mount Sinai Medical Center
  • Cleveland Clinic Foundation
  • University of Pennslyvania
  • University Of Pittsburgh Medical Center
  • Vanderbilt University Medical Center
  • Royal Alexandra Hospital
  • St. Michael's Hospital
  • University Health Network - Toronto General Hospital
  • Rigshospitalet
  • Hôpital Beaujon
  • Hopital de l'Archet 2
  • Med. Klinik m.S. Hepatologie und Gastroenterologie
  • Universitaetsklinikum Tuebingen Medizinische Klinik I
  • Azienda Universitaria Policlinico Federico II
  • Wojewodzki Szpital Specjalistyczny im. M. Pirogowa, Pracownia Leczenia Zywieniowego
  • Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Chirurgii Ogolnej i Transplantacyjnej
  • Pracownia Żywienia Klinicznego
  • Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP
  • Hospital Universitario de Bellvitge
  • Hospital Universitario 12 de Octubre
  • St. Marks Hospital
  • University College London Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

teduglutide

Arm Description

0.05 mg/kg/day

Outcomes

Primary Outcome Measures

Percent Change in PN/IV Volume by Visit
The mean change from baseline in weekly PN.IV volume in percent change is shown by visit.
Absolute Change in PN/IV Volume by Visit
The mean change from baseline in weekly PN.IV volume in Liters is shown by visit.

Secondary Outcome Measures

Number of Subjects Achieving PN/IV Reduction
The number of subjects who achieve at least 1-, 2-, and 3-day reductions in PN/IV per Week.

Full Information

First Posted
June 26, 2009
Last Updated
June 3, 2021
Sponsor
Shire
Collaborators
Nycomed Germany GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00930644
Brief Title
Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)
Official Title
A Long-Term, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition Dependent Short Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 21, 2009 (Actual)
Primary Completion Date
January 24, 2013 (Actual)
Study Completion Date
January 24, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
Collaborators
Nycomed Germany GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Bowel Syndrome
Keywords
short bowel syndrome, parenteral nutrition, PN, HPN, TPN, SBS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
teduglutide
Arm Type
Experimental
Arm Description
0.05 mg/kg/day
Intervention Type
Drug
Intervention Name(s)
teduglutide
Other Intervention Name(s)
Gattex
Intervention Description
0.05 mg/kg/day subcutaneously taken once per day for 24 months
Primary Outcome Measure Information:
Title
Percent Change in PN/IV Volume by Visit
Description
The mean change from baseline in weekly PN.IV volume in percent change is shown by visit.
Time Frame
24 months
Title
Absolute Change in PN/IV Volume by Visit
Description
The mean change from baseline in weekly PN.IV volume in Liters is shown by visit.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Number of Subjects Achieving PN/IV Reduction
Description
The number of subjects who achieve at least 1-, 2-, and 3-day reductions in PN/IV per Week.
Time Frame
24 Months or Last Dosing Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: must have completed 24 weeks of dosing of the CL0600-020 study Exclusion Criteria: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Scripps Clinic & Research Foundation
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pennslyvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University Of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 4B9
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B1W8
Country
Canada
Facility Name
University Health Network - Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Rigshospitalet
City
København
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Hôpital Beaujon
City
Clichy
Country
France
Facility Name
Hopital de l'Archet 2
City
Nice
Country
France
Facility Name
Med. Klinik m.S. Hepatologie und Gastroenterologie
City
Berlin
State/Province
BE
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen Medizinische Klinik I
City
Tuebingen
State/Province
BW
ZIP/Postal Code
72076
Country
Germany
Facility Name
Azienda Universitaria Policlinico Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Wojewodzki Szpital Specjalistyczny im. M. Pirogowa, Pracownia Leczenia Zywieniowego
City
Lodz
ZIP/Postal Code
90-531
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Chirurgii Ogolnej i Transplantacyjnej
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Pracownia Żywienia Klinicznego
City
Olsztyn
ZIP/Postal Code
10-651
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP
City
Warsaw
ZIP/Postal Code
00-416
Country
Poland
Facility Name
Hospital Universitario de Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
St. Marks Hospital
City
Harrow
ZIP/Postal Code
HA13UJ
Country
United Kingdom
Facility Name
University College London Hospital
City
London
ZIP/Postal Code
WC1E 6DB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
16099790
Citation
Jeppesen PB, Sanguinetti EL, Buchman A, Howard L, Scolapio JS, Ziegler TR, Gregory J, Tappenden KA, Holst J, Mortensen PB. Teduglutide (ALX-0600), a dipeptidyl peptidase IV resistant glucagon-like peptide 2 analogue, improves intestinal function in short bowel syndrome patients. Gut. 2005 Sep;54(9):1224-31. doi: 10.1136/gut.2004.061440.
Results Reference
background
PubMed Identifier
32341691
Citation
Pape UF, Iyer KR, Jeppesen PB, Kunecki M, Pironi L, Schneider SM, Seidner DL, Lee HM, Caminis J. Teduglutide for the treatment of adults with intestinal failure associated with short bowel syndrome: pooled safety data from four clinical trials. Therap Adv Gastroenterol. 2020 Apr 20;13:1756284820905766. doi: 10.1177/1756284820905766. eCollection 2020.
Results Reference
derived

Learn more about this trial

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

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