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

Phase 3

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Matching subcutaneous dose of placebo to teduglutide
Teduglutide	teduglutide	0.05 mg/kg/day sc dose of teduglutide

Primary Outcome Measures

Name	Time	Method
Responder	Weeks 20 and 24	Comparison of subjects treated with teduglutide to placebo who achieve a 20 to 100% reduction from baseline in weekly parenteral nutrition/intravenous fluid (PN/I.V.) volume at weeks 20 and 24.

Secondary Outcome Measures

Name	Time	Method
Absolute Change in PN/I.V. Volume From Baseline to Last Time Point	Week 0 to last visit when data was collected.	Absolute change in the volume of PN/I.V. from baseline (Week 0) to the visit when the last data point was collected (week 4 through week 24, or earlier if the subject discontinued early).

Locations (35): Scripps Clinic & Research Foundation
🇺🇸
La Jolla, California, United States
Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
Mayo Clinic Jacksonville
🇺🇸
Jacksonville, Florida, United States
Emory University School of Medicine
🇺🇸
Atlanta, Georgia, United States
Kansas University Medical Center
🇺🇸
Kansas City, Kansas, United States
Mount Sinai Medical Center
🇺🇸
New York, New York, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
University of Pennslyvania
🇺🇸
Philadelphia, Pennsylvania, United States
University Of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
🇺🇸
Providence, Rhode Island, United States
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Scripps Clinic & Research Foundation
🇺🇸La Jolla, California, United States