A study of the Efficacy and Safety of Teduglutide in subjects with Parenteral Nutritional Dependant Short Bowel Syndrome - N/A

PS Allelix Corporation0 sites125 target enrollmentAugust 27, 2004

Overview

No summary available.

Registry

who.int

Start Date

August 27, 2004

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

PS Allelix Corporation

•Subjects who meet all of the following criteria can be enrolled in this study:
•1\.Signed and dated informed consent form (ICF) before any study\-related procedures are performed
•2\.Men and women, aged 18 years of age or older at the time of signing the ICF
•3\.SBS as a result of major in testinal resection, e.g., due to injury, volvulus, vascular disease, cancer, Crohn’s disease
•a.For subjects with a history of cancer (there are exceptions listed in Sec. 4\.3 Exclusion criteria), the subject should be disease\-free for at least 5 years
•b.For subjects with a history of Crohn’s disease, the subject should be in clinical remission, as determined by clinical assessment
•4\.Body weight must be less than 90 kg at the time of enrollment
•5\.Major intestinal resection resulting in at least 12 months dependency prior PN to the date of the signature of ICF. Minor ostomy revisions within this time period are allowable
•6\.At baseline, subjects must require PN treatment to meet their caloric or electrolyte needs due to ongoing malabsorption at least 3 times weekly
•7\.Stable for at least 4 consecutive weeks just prior to randomization in:

•Subjects who meet any of the following criteria will be excluded:
•1\.History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease\-free state. This does not include resected cutaneous basal or squamous cell carcinoma, or in situ cervical cancer.
•2\.History of alcohol or drug abuse (within previous year)
•3\.Participation in a clinical study within 30 days prior to signing the ICF, or concurrent participation in any clinical study
•4\.Clinically significant laboratory abnormalities at the time of randomization
•5\.Previous use of teduglutide (ALX\-0600\)
•6\.Prior use of native GLP\-2 within 3 months of screening visit
•7\.Hospital admission within 1 month prior to screening visit
•8\.Pregnant or lactating women
•9\.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