Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT00081458
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00081458
Study Brief:
Protocol Section:
NCT00081458