Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Intervention: Placebo; Teduglutide 0.05 mg/kg/d; Teduglutide 0.1 mg/kg/d
Intervention description: placebo injectable subcutaneously daily into thigh or abdomen; Teduglutide 0.05 mg/kg/d daily injectable subcutaneously into the thigh or abdomen; Teduglutide 0.1 /g/kg/d daily injection subcutaneously into thigh or abdomen
Intervention MeSH terms: Teduglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Short Bowel Syndrome; Parenteral Nutrition; SBS

Summary:

      The purpose of this study is to evaluate the efficacy, safety, tolerability, and
      pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral
      nutrition (PN)-dependent short bowel syndrome (SBS).
    

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