Short Bowel Syndrome Clinical Trial
Official title:
A Study of the Efficacy and Safety of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome
Verified date | May 2021 |
Source | Takeda |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 84 |
Est. completion date | July 6, 2007 |
Est. primary completion date | July 6, 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | l'Hôpital Erasme | Brussels | |
Canada | Royal Alexandra Hospital | Edmonton | Alberta |
Canada | St. Michael's Hospital | Toronto | Ontario |
Canada | Toronto General Hospital | Toronto | Ontario |
Canada | St. Paul's Hospital | Vancouver | British Columbia |
Denmark | Rigshospitalet, University of Copenhagen | Copenhagen | |
France | Hôpital Claude-Huriez | Lille | |
France | Hôpital de la Croix-Rousse | Lyon | |
France | Hôpital Edouard Herriot | Lyon | |
France | Hôpital Beaujon | Paris | |
Germany | Charité University Hospital | Berlin | |
Germany | Charité-Universitätsmedizin Berlin | Berlin | |
Germany | Universitätsklinikum Frankfurt | Frankfurt | |
Netherlands | Academic Medical Center | Amsterdam | |
Poland | Pracownia Zywienia Klinicznego | Olsztyn | |
Poland | Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orlowskiego CMKP | Warsaw | |
United Kingdom | St. Mark's Hospital | Harrow | |
United Kingdom | Hope Hospital | Salford | Greater Manchester |
United States | Albany Medical Center | Albany | New York |
United States | Emory University Hospital | Atlanta | Georgia |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Northwestern Center for Clinical Research | Chicago | Illinois |
United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | Mount Sinai School of Medicine | New York | New York |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | University of Pennsylvania - Penn Nursing | Philadelphia | Pennsylvania |
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | University of Rochester Medical Center | Rochester | New York |
United States | Mayo Clinic Scottsdale | Scottsdale | Arizona |
United States | Georgetown University | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Shire |
United States, Belgium, Canada, Denmark, France, Germany, Netherlands, Poland, United Kingdom,
Dudrick SJ, Latifi R, Fosnocht DE. Management of the short-bowel syndrome. Surg Clin North Am. 1991 Jun;71(3):625-43. Review. — View Citation
Jeppesen PB, Gilroy R, Pertkiewicz M, Allard JP, Messing B, O'Keefe SJ. Randomised placebo-controlled trial of teduglutide in reducing parenteral nutrition and/or intravenous fluid requirements in patients with short bowel syndrome. Gut. 2011 Jul;60(7):90 — View Citation
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. — View Citation
Shanbhogue LK, Molenaar JC. Short bowel syndrome: metabolic and surgical management. Br J Surg. 1994 Apr;81(4):486-99. Review. — View Citation
Vanderhoof JA, Langnas AN. Short-bowel syndrome in children and adults. Gastroenterology. 1997 Nov;113(5):1767-78. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | A Graded Response Score in Parenteral Nutrition (PN) Reduction | The intensity of the response relied on a reduction from Baseline in weekly parenteral nutrition (PN) volume (minimum reduction of 20% and a maximum of 100%). Duration of the response incorporated responses at Weeks(Wk) 16-20 and at Wk20-24. Zero (0 - lowest) assigned if <20% reduction at Wk20-24 and reduction at Wk16-20 of < 20%, 20-39%, or >=40%. One (1) assigned if reduction of 20-39% at Wk20-24 but < 20% at Wk16-20. Two(2) assigned if reductions of 40-99% at Wk20-24 AND <20% at Wk16-20 OR 20-39% at Wk20-24 AND 20-39% at Wk16-20. Three (3) assigned if reductions of 100% at Wk20-24 AND <20% at Wk16-20 OR 40-99% at Wk20-24 AND 20-39% at Wk16-20 OR 20-39% at Wk20-24 AND >=40% at Wk16-20. Four (4) assigned if reductions of 100% at Wk20-24 AND 20-39% at Wk16-20 OR 40-99% at Wk20-24 AND >=40% at Wk16-20. | 6 months | |
Secondary | Number of Subjects Achieving Binary Response at Week 20, Maintained at Week 24 | An efficacy responder was defined as achieving at least a 20% reduction from Baseline to Week 20 and maintained at Week 24 in weekly actual PN infusion volume. | 6 months of treatment |
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