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

Completed · Phase 3 · Has a placebo group

Conditions studied: Short Bowel Syndrome

In brief

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.

Key facts

Study ID

NCT00798967

Run by

Shire

People needed

86

Starts

2008-11-25

Expected to finish

2011-01-25

Last updated by the study team

2021-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Scripps Clinic & Research Foundation — La Jolla, California, United States
• Washington Hospital Center — Washington D.C., 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
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Critical Care Research, Royal Alexandra Hospital — Edmonton, Alberta, Canada
• Hamilton Health Sciences Centre — Hamilton, Ontario, Canada
• Polyclinic Family and Specialty Medicine Facility — North York, Ontario, Canada
• University Health Network - Toronto General Hospital — Toronto, Ontario, Canada
• Rigshospitalet - Abdominalcentret, Hepatologisk Kilinik A — Copenhagen, Denmark
• Hôpital Beaujon — Clichy, France
• Hôpital Croix Rousse Unité de Nutrition Clinique Intensive — Lyon, France
• Hôpital de l'Archet Pôle Digestif — Nice, France
• Universitaetsklinikum Tuebingen — Tübingen, Baden-Wurttemberg, Germany
• Israelitisches Krankenhaus — Hamburg, Free and Hanseatic City of Hamburg, Germany
• Med. Klinik m.S. Hepatologie und Gastroenterologie — Berlin, State of Berlin, Germany
• Azienda Ospedaliera Universitaria S. Giovanni Battista - Le Molinette — Torino, TO, Italy
• Policlinico Sant'Orsola - Malpighi centro insufficienza intestinale — Bologna, Italy
• Azienda Universitaria Policlinico Federico II — Naples, Italy

Full record on ClinicalTrials.gov

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