A 24-Week Study of the Efficacy and Safety of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome
Overview
- Phase
- Phase 3
- Intervention
- teduglutide
- Conditions
- Short Bowel Syndrome
- Sponsor
- Shire
- Enrollment
- 86
- Locations
- 35
- Primary Endpoint
- Responder
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Teduglutide
0.05 mg/kg/day sc dose of teduglutide
Intervention: teduglutide
Placebo
Matching subcutaneous dose of placebo to teduglutide
Intervention: placebo
Outcomes
Primary Outcomes
Responder
Time Frame: 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 Outcomes
- Absolute Change in PN/I.V. Volume From Baseline to Last Time Point(Week 0 to last visit when data was collected.)