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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07319832
Eligibility Criteria:
Inclusion criteria
* Children and adolescents greater than or equal to (\>=)1 through 17 years of age at Day 1 (D1).
* Documented diagnosis of SBS.
* Received or plan to receive Teduglutide treatment for a minimum of 24 weeks.
* Stable PN/IV support, defined as inability to significantly reduce PN/IV support, usually associated with minimal or no advance in enteral feeds (i.e., 10% or less change in PN or advance in feeds) for at least 3 months prior to D1, as assessed by the investigator. Transient instability for events such as interruption of central access or treatment for sepsis is allowed if the PN/IV support returns to within 10% of baseline prior to the event.
* Informed consent obtained from the patient aged 8 to 17 years and their guardians, while informed consent from the guardians for participants under 8 years old, unless waived by the Institution's Ethics Committee.
Exclusion criteria
* Participants who are not expected to be able to advance oral or tube feeding regimens.
* Serial Transverse Enteroplasty (STEP) or any other bowel lengthening procedure performed within 3 months prior to baseline.
* Known clinically significant untreated intestinal obstruction contributing to feeding intolerance and inability to reduce PS.
* Evidence of clinically significant obstruction on upper GI series done within 6 months prior to baseline.
* Previous use of octreotide or Dipeptidyl peptidase-4 (DPP-4) inhibitors within 3 months prior to baseline.
* Signs of active, severe, or unstable clinically significant hepatic impairment during the screening or baseline period, indicative by any of the following laboratory test results:
1. Total Bilirubin Level (TBL) \>= 2 × upper limit of normal (ULN)
2. Aspartate Aminotransferase (AST) \>=7 × ULN
3. Alanine Aminotransferase (ALT) \>=7 × ULN
For Participants with Gilbert's disease:
4. Indirect (unconjugated) bilirubin \>=2 × ULN
* Signs of known continuous active or unstable, clinically significant renal dysfunction shown by results of an estimated glomerular filtration rate (eGFR) below 50 millilitres per minutes per 1.73 meter square (mL/min/1.73 m\^2).
* Known hypersensitivity of the active substance or excipient of teduglutide.
* Body weight less than (\<) 10 kg at baseline.
* Previous use of teduglutide or native/synthetic Glucagon-like Peptide-2 (GLP-2).
* Previous use of GLP-1 analog or human growth hormone within 3 months prior to baseline.
* Any condition, disease, illness, or circumstance that in the investigator's opinion puts the patient at any undue risk, prevents completion of the study, or interferes with analysis of the study results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
17 Years
Study:
NCT07319832
Study Brief:
Protocol Section:
NCT07319832