Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects

Short Bowel Syndrome Clinical Trial

— STEPS  

Official title:

A 24-Week Study of the Efficacy and Safety of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00798967
• Other study ID #: CL0600-020
• Secondary ID: 2008-006193-15
• Status: Completed
• Phase: Phase 3
• Start date: November 25, 2008
• Est. completion date: January 25, 2011

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Teduglutide is an investigative medicine being evaluated as a possible treatment for people with parenteral nutrition (PN) dependent Short Bowel Syndrome (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. This study was designed to provide evidence of efficacy, safety, and tolerability of teduglutide 0.05 mg/kg daily in SBS subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 25, 2011
• Est. primary completion date: January 25, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed and dated informed consent prior to any study-related procedures are performed
• Men and women 18 years of age or older at the time of informed consent signing
• Intestinal failure resulting in Short Bowel Syndrome
• At least 12 months of continuous PN dependency
• 12 weeks of clinical remission of Crohn's disease (CD) prior to dosing
• PN required at least 3 times weekly
• A stable PN volume for four weeks prior to dosing

Exclusion Criteria:

• History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state
• Participation in clinical study within 30 days for drug or 90 days for antibody
• Use of native GLP-2 or human growth hormone (HGH) within 6 months of screening
• Use of iv glutamine within 30 days prior to screening
• Use of teduglutide
• CD patients who have been treated with biological therapy within 6 months of screening
• IBD patients who require chronic systemic immunosuppressant therapy
• More than 4 SBS- or PN-related hospitalizations within 12 months of screening
• Unplanned hospitalization within one month of screening
• Pregnant or lactating women
• Body weight > 88kg
• Body mass index (BMI) < 15 kg/m2
• Severe hepatic impairment or disturbed renal function
• Female subjects who are not surgically sterile or postmenopausal or who are not using medically acceptable methods of birth control during and for 30 days after the treatment period
• Not capable of understanding or not willing to adhere to the study visit schedules and other protocol requirements
• Any condition or circumstance that is the investigator's opinion would put the subject at any undue risk, prevent completion of the study, or interfere with the analysis of the study results
• Significant active, uncontrolled, untreated systemic diseases

Related Conditions & MeSH terms

• Short Bowel Syndrome
• Syndrome

Intervention

Drug:
• teduglutide
0.05 mg/kg/day sc injection for 24 weeks
• placebo
Matching daily subcutaneous dose of placebo to teduglutide for 24 weeks

Locations

Country	Name	City	State
Canada	Critical Care Research, Royal Alexandra Hospital	Edmonton	Alberta
Canada	Hamilton Health Sciences Centre	Hamilton	Ontario
Canada	Polyclinic Family and Specialty Medicine Facility	North York	Ontario
Canada	University Health Network - Toronto General Hospital	Toronto	Ontario
Denmark	Rigshospitalet - Abdominalcentret, Hepatologisk Kilinik A	København
France	Hôpital Beaujon	Clichy
France	Hôpital Croix Rousse Unité de Nutrition Clinique Intensive	Lyon
France	Hôpital de l'Archet Pôle Digestif	Nice Cedex 3
Germany	Med. Klinik m.S. Hepatologie und Gastroenterologie	Berlin	BE
Germany	Israelitisches Krankenhaus	Hamburg	HH
Germany	Universitaetsklinikum Tuebingen	Tuebingen	BW
Italy	Policlinico Sant'Orsola - Malpighi centro insufficienza intestinale	Bologna
Italy	Azienda Universitaria Policlinico Federico II	Napoli
Italy	Azienda Ospedaliera Universitaria S. Giovanni Battista - Le Molinette	Torino	TO
Netherlands	Universitair Medisch Centrum St. Radboud	Nijmegen
Poland	Wojewodzki Szpital Specjalistyczny im. M. Pirogowa, Pracownia Leczenia Zywieniowego	Lodz
Poland	Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Chirurgii Ogolnej i Transplantacyjnej	Lublin
Poland	Wojewodzki Szpital Specjalistyczny,	Olsztyn
Poland	Samodzielny Publiczny Szpital Kliniczny im. prof W. Orlowskiego CMKP, Oddzial Kliniczny Zywienia i Chirurgii	Warsaw
Spain	Hospital Universitario de Bellvitge	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
United Kingdom	St. Mark's Hospital Northwick Park	Harrow	Gt Lon
United Kingdom	University College Hospital	London	Gt Lon
United Kingdom	Green Area, Main Hospital Salford Royal Hospitals NHS Foundation Trust	Manchester	Gt Man
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Scripps Clinic & Research Foundation	La Jolla	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Mount Sinai Medical Center	New York	New York
United States	University of Pennslyvania	Philadelphia	Pennsylvania
United States	University Of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Shire	Nycomed

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  France,  Germany,  Italy,  Netherlands,  Poland,  Spain,  United Kingdom, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responder	Comparison of subjects treated with teduglutide to placebo who achieve a 20 to 100% reduction from baseline in weekly parenteral nutrition/intravenous fluid (PN/I.V.) volume at weeks 20 and 24.	Weeks 20 and 24
Secondary	Absolute Change in PN/I.V. Volume From Baseline to Last Time Point	Absolute change in the volume of PN/I.V. from baseline (Week 0) to the visit when the last data point was collected (week 4 through week 24, or earlier if the subject discontinued early).	Week 0 to last visit when data was collected.