Short Bowel Syndrome Clinical Trial
Official title:
A Study of the Safety and Efficacy of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)
Verified date | May 2021 |
Source | Takeda |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.
Status | Completed |
Enrollment | 65 |
Est. completion date | January 24, 2008 |
Est. primary completion date | January 24, 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: At dosing week 24 of protocol CL0600-004 (NCT00081458), subjects will be reviewed for their participation in this study. Subjects who meet all of the following criteria can be enrolled in this study: - Signed and dated informed consent form (ICF) to participate before any study-related procedures are performed - Completion of protocol CL0600-004 (NCT00081458) 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) - Prior use of native glucagon-like peptide 2 (GLP-2) within 3 months of 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Hôpital Erasme | Brussels | |
Canada | St. Michael's Hospital | Toronto | Ontario |
Canada | Toronto General Hospital | Toronto | Ontario |
Canada | St. Paul's Hospital | Vancouver | British Columbia |
Denmark | Rigshospitalet | Copenhagen | |
France | Hôpital Huriez | Lille | |
France | Hôpital de la Croix-Rousse | Lyon | |
France | Hôpital Lariboisière | Paris | |
Netherlands | Academic Medical Center, Department of Endocrinology & Metabolism | Amsterdam | |
Poland | Pracownia Zywienia | Olsztyn | |
Poland | Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orlowskiego CMKP | Warsaw | |
United Kingdom | St. Mark's Hospital | Harrow | |
United States | Albany Medical Center | Albany | New York |
United States | Emory University Hospital | Atlanta | Georgia |
United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
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 |
Lead Sponsor | Collaborator |
---|---|
Shire |
United States, Belgium, Canada, Denmark, France, Netherlands, Poland, United Kingdom,
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
O'Keefe SJ, Jeppesen PB, Gilroy R, Pertkiewicz M, Allard JP, Messing B. Safety and efficacy of teduglutide after 52 weeks of treatment in patients with short bowel intestinal failure. Clin Gastroenterol Hepatol. 2013 Jul;11(7):815-23.e1-3. doi: 10.1016/j. — View Citation
Vipperla K, O'Keefe SJ. Study of teduglutide effectiveness in parenteral nutrition-dependent short-bowel syndrome subjects. Expert Rev Gastroenterol Hepatol. 2013 Nov;7(8):683-7. doi: 10.1586/17474124.2013.842894. Epub 2013 Oct 17. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects Achieving a 20% Reduction at Week 28 | For those subjects who received teduglutide (0.05 or 0.10 mg dose) in Study 004 and the same in Study 005, Parenteral Nutrition (PN) Use at Week 28 was compared to the Baseline Visit of Study 004 to calculate the 20% reduction in PN Use. For those subjects who received placebo in Study 004 and either teduglutide 0.05 or 0.10 mg dose in Study 005, PN Use at Week 28 was compared to the use of PN at Week 24 of Study 004 to calculate the 20% reduction in PN Use. | 28 weeks | |
Secondary | Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use | Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use (Responder Status is Yes or No) | 6 months |
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