Status:
COMPLETED
Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects
Lead Sponsor:
Shire
Collaborating Sponsors:
Nycomed
Conditions:
Short Bowel Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 25 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2011
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00798967
Start Date
November 25 2008
End Date
January 25 2011
Last Update
June 3 2021
Active Locations (35)
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1
Scripps Clinic & Research Foundation
La Jolla, California, United States, 92037
2
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
3
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
4
Emory University School of Medicine
Atlanta, Georgia, United States, 30322