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
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