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Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome

Information source: NPS Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Short Bowel Syndrome

Intervention: Placebo (Drug); Teduglutide 0.05 mg/kg/d (Drug); Teduglutide 0.1 mg/kg/d (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: NPS Pharma

Official(s) and/or principal investigator(s):
Head Clinical Development, Study Director, Affiliation: NPS

Summary

The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS).

Clinical Details

Official title: A Study of the Efficacy and Safety of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: A Graded Response Score in Parenteral Nutrition (PN) Reduction

Secondary outcome: Number of Subjects Achieving Binary Response at Week 20, Maintained at Week 24

Detailed description: Teduglutide is an analog of glucagon-like peptide 2 (GLP-2), a naturally occurring hormone that regulates the growth, proliferation, and maintenance of cells lining the gastrointestinal tract. Teduglutide has been shown in animal studies and previous human clinical trials to increase the size and number of these cells, thereby increasing the absorptive surface area of the intestines. The multicenter, double-blind, international Phase III trial will randomly assign approximately 80 patients to receive daily subcutaneous injections of 0. 05 milligrams or 0. 10 milligrams of teduglutide per kilogram of body weight, or a placebo. Dosing will continue for a period of six months. The primary endpoint in the study is a reduction in the use of intravenous feeding, which is often required to sustain life in patients with SBS.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Men and women, aged 18 years of age or older at the time of signing the informed

consent form (ICF)

- SBS as a result of major intestinal resection resulting in at least 12 months

intravenous feeding

- Body weight must be less than 90 kg

- At baseline, subjects must require PN treatment to meet their caloric or electrolyte

needs due to ongoing malabsorption at least 3 times weekly and to be on a stable PN regimen for 4 weeks before dosing

- Body mass index (BMI) 18 to 27 kg/m2

- Adequate hepatic and renal function

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)

- Participation in a clinical study within 30 days prior to signing the ICF, or

concurrent participation in any clinical study

- Clinically significant laboratory abnormalities at the time of randomization

- Previous use of teduglutide (ALX-0600)

- Prior use of native GLP-2 within 3 months of screening visit

- Hospital admission within 1 month prior to 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.

- Presence of excluded disease: Radiation enteritis, Scleroderma, Celiac disease,

Refractory/Tropical sprue, Pseudo-obstruction, Active inflammatory bowel disease (IBD), Pre-malignant/malignant change in colonoscopy biopsy or polypectomy, Surgery scheduled within the time frame of the study, Human immunodeficiency virus (HIV) positive test, Immunological disorders, Possible allergies to teduglutide or its constituents, Significant, active, uncontrolled, untreated systemic diseases

Locations and Contacts

l'Hôpital Erasme, Brussels 1070, Belgium

Rigshospitalet, University of Copenhagen, Copenhagen 2100, Denmark

Hôpital Claude-Huriez, Lille 59037, France

Hôpital de la Croix-Rousse, Lyon 69317, France

Hôpital Edouard Herriot, Lyon 69437, France

Hôpital Beaujon, Paris 92110, France

Charité University Hospital, Berlin 10117, Germany

Charité-Universitätsmedizin Berlin, Berlin 13353, Germany

Universitätsklinikum Frankfurt, Frankfurt 60590, Germany

Academic Medical Center, Amsterdam 1100 DD, Netherlands

Pracownia Żywienia Klinicznego, Olsztyn 10-651, Poland

Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP, Warsaw 00-416, Poland

St. Mark's Hospital, Harrow HA13UJ, United Kingdom

Royal Alexandra Hospital, Edmonton, Alberta T5H4B9, Canada

Mayo Clinic Scottsdale, Scottsdale, Arizona 85259, United States

St. Paul's Hospital, Vancouver, British Columbia V6Z1Y6, Canada

Georgetown University, Washington, District of Columbia 20007, United States

Emory University Hospital, Atlanta, Georgia 30322, United States

Hope Hospital, Salford, Greater Manchester M68HD, United Kingdom

Northwestern Center for Clinical Research, Chicago, Illinois 60611, United States

University of Kansas Medical Center, Kansas City, Kansas 66160, United States

University of Nebraska Medical Center, Omaha, Nebraska 68198, United States

Albany Medical Center, Albany, New York 12208, United States

Mount Sinai School of Medicine, New York, New York 10029, United States

University of Rochester Medical Center, Rochester, New York 14642, United States

The Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States

St. Michael's Hospital, Toronto, Ontario M5B1W8, Canada

Toronto General Hospital, Toronto, Ontario M5G2N2, Canada

University of Pennsylvania - Penn Nursing, Philadelphia, Pennsylvania 19104, United States

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, United States

Rhode Island Hospital, Providence, Rhode Island 02903, United States

Medical University of South Carolina, Charleston, South Carolina 29425, United States

Additional Information

Click here for accurate, up-to-date, and practical information for patients with Short Bowel Syndrome (SBS).

Related publications:

Dudrick SJ, Latifi R, Fosnocht DE. Management of the short-bowel syndrome. Surg Clin North Am. 1991 Jun;71(3):625-43. Review.

Rombeau JL, Rolandelli RH. Enteral and parenteral nutrition in patients with enteric fistulas and short bowel syndrome. Surg Clin North Am. 1987 Jun;67(3):551-71.

Shanbhogue LK, Molenaar JC. Short bowel syndrome: metabolic and surgical management. Br J Surg. 1994 Apr;81(4):486-99. Review.

Vanderhoof JA, Langnas AN. Short-bowel syndrome in children and adults. Gastroenterology. 1997 Nov;113(5):1767-78. Review.

Starting date: April 2004
Last updated: September 26, 2014

Page last updated: August 23, 2015

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