Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects

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

Teduglutide is an investigative medicine being evaluated as a possible treatment for people with parenteral nutrition (PN) dependent Short Bowel Syndrome (SBS). Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. This study was designed to provide evidence of efficacy, safety, and tolerability of teduglutide 0.05 mg/kg daily in SBS subjects.

Inclusion Criteria:

• Signed and dated informed consent prior to any study-related procedures are performed
• Men and women 18 years of age or older at the time of informed consent signing
• Intestinal failure resulting in Short Bowel Syndrome
• At least 12 months of continuous PN dependency
• 12 weeks of clinical remission of Crohn's disease (CD) prior to dosing
• PN required at least 3 times weekly
• A stable PN volume for four weeks prior to dosing

Exclusion Criteria:

• History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state
• Participation in clinical study within 30 days for drug or 90 days for antibody
• Use of native GLP-2 or human growth hormone (HGH) within 6 months of screening
• Use of iv glutamine within 30 days prior to screening
• Use of teduglutide
• CD patients who have been treated with biological therapy within 6 months of screening
• IBD patients who require chronic systemic immunosuppressant therapy
• More than 4 SBS- or PN-related hospitalizations within 12 months of screening
• Unplanned hospitalization within one month of screening
• Pregnant or lactating women
• Body weight > 88kg
• Body mass index (BMI) < 15 kg/m2
• Severe hepatic impairment or disturbed renal function
• Female subjects who are not surgically sterile or postmenopausal or who are not using medically acceptable methods of birth control during and for 30 days after the treatment period
• Not capable of understanding or not willing to adhere to the study visit schedules and other protocol requirements
• Any condition or circumstance that is the investigator's opinion would put the subject at any undue risk, prevent completion of the study, or interfere with the analysis of the study results
• Significant active, uncontrolled, untreated systemic diseases