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

NCT00930644 | Completed Phase 3 Results DMC

• 2 other identifiers: CL0600-0212009-011679-65
• Study Type: interventional
• Target: 88
• Locations: 9 countries
• Sites: 23

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.

Conditions

Short Bowel Syndrome

Keywords

short bowel syndrome; parenteral nutrition; PN; HPN; TPN; SBS

Outcome Measures

Primary Outcomes (2)

• 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.

  24 months

• Absolute Change in PN/IV Volume by Visit

  The mean change from baseline in weekly PN.IV volume in Liters is shown by visit.

  24 months

Secondary Outcomes (1)

• Number of Subjects Achieving PN/IV Reduction

  24 Months or Last Dosing Visit

Study Arms (1)

teduglutide

EXPERIMENTAL

0.05 mg/kg/day

Drug: teduglutide

Interventions

teduglutide DRUG

0.05 mg/kg/day subcutaneously taken once per day for 24 months

Also known as: Gattex

teduglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Shire: lead
• Nycomed Germany GmbH: collaborator

Study Sites (23)

Scripps Clinic & Research Foundation

La Jolla, California, 92037, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Pennslyvania

Philadelphia, Pennsylvania, 19104, United States

Location

University Of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Royal Alexandra Hospital

Edmonton, Alberta, T5H 4B9, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

University Health Network - Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Hôpital Beaujon

Clichy, France

Location

Hopital de l'Archet 2

Nice, France

Location

Universitaetsklinikum Tuebingen Medizinische Klinik I

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Med. Klinik m.S. Hepatologie und Gastroenterologie

Berlin, State of Berlin, 13353, Germany

Location

Azienda Universitaria Policlinico Federico II

Napoli, 80131, Italy

Location

Wojewodzki Szpital Specjalistyczny im. M. Pirogowa, Pracownia Leczenia Zywieniowego

Lodz, 90-531, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Chirurgii Ogolnej i Transplantacyjnej

Lublin, 20-090, Poland

Location

Pracownia Żywienia Klinicznego

Olsztyn, 10-651, Poland

Location

Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP

Warsaw, 00-416, Poland

Location

Hospital Universitario de Bellvitge

Barcelona, 08907, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

St. Marks Hospital

Harrow, HA13UJ, United Kingdom

Location

University College London Hospital

London, WC1E 6DB, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 16099790 BACKGROUND

• 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.

  PMID: 32341691 DERIVED

MeSH Terms

Conditions

Short Bowel Syndrome; Hyperphagia

Interventions

teduglutide; ALX-0600

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2009
• First Posted: June 30, 2009
• Study Start: September 21, 2009
• Primary Completion: January 24, 2013
• Study Completion: January 24, 2013
• Last Updated: June 11, 2021
• Results First Posted: December 24, 2014

Record last verified: 2021-06

Locations

DK (1); CA (3); ES (2); GB (2); FR (2); IT (1); PL (4); DE (2); US (6)