A 24-Week Study of the Efficacy and Safety of Teduglutide in Subjects with Parenteral Nutrition-Dependent Short Bowel Syndrome

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 86

Inclusion Criteria

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, 18 years of age or older at the time of signing the ICF
3. Intestinal failure resulting in SBS as a consequence of major intestinal resection (eg, due to injury, volvulus, vascular disease, cancer, Crohn’s disease)
4. For subjects with a history of Crohn’s disease, the subject should be in clinical remission for at least 12 weeks prior to dosing as demonstrated by clinical assessment, which may include procedure-based evidence of remission
5. Subjects who have undergone intestinal resection resulting in at least 12 continuous months of parenteral nutrition (PN) dependency prior to signature of ICF
6. PN required at least 3 times per week during the week before screening and during the 2 weeks prior to baseline to meet their caloric, fluid, or electrolyte needs due to ongoing malabsorption
7. Stable PN for at least 4 consecutive weeks immediately prior to randomization based upon the opinion of the investigator and approval of NPS. Stability is described as:
a. Actual PN/IV usage should match prescribed PN/IV
b. Baseline 48-hour oral fluid intake and urine output (I/O) volumes should fall
within ±25% of the respective 48-hour I/O volumes at the time subject enters stabilization.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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 non-aggressive and surgically resected cancer.
2. Participation in a clinical study using an experimental drug within 30 days or an
experimental antibody treatment within 90 days prior to signing the ICF, or concurrent participation in any clinical study using an experimental drug.
3. Previous use of native GLP-2 or human growth hormone (HGH) within 6 months
prior to screening
4. Previous use of iv glutamine within 30 days prior to screening
5. Previous use of teduglutide
6. Subjects with Crohn’s disease who have been treated with biological therapy (eg,
anti-TNF or natalizumab) within the 6 months prior to screening
7. Subjects with inflammatory bowel disease (IBD) who require chronic systemic
immunosuppressant therapy for symptom control
8. More than 4 SBS-related or PN-related hospital admissions (eg, catheter sepsis,
bowel obstruction, severe water-electrolytes disturbances) within 12 months prior to
screening visit
9. Hospital admission, other than scheduled, within 1 month prior to screening
10. Pregnant or lactating women
11. Body weight > 88 kg
12. Body mass index (BMI) <15 kg/m2
13. Signs of severe hepatic impairment or disturbed renal function:
a. Total bilirubin = 2xULN - For subjects with Gilbert’s disease, direct (conjugated) bilirubin = 2xULN.
b. Aspartate aminotransferase (AST) = 5xULN
b. Serum creatinine = 2xULN
14. Female subjects who are not surgically sterile or postmenopausal and who are not using medically acceptable methods of birth control during and for 30 days after the treatment period. Postmenopausal is defined as aged 55 years or older and/or 2 years must have elapsed since the last menses.
15. Not capable of understanding or not willing to adhere to the study visit schedule and other protocol requirements.
16. Any condition or circumstance that 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials