Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects
- Registration Number
- NCT00798967
- Lead Sponsor
- Shire
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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).
Trial Locations
- Locations (35)
University of Pennslyvania
🇺🇸Philadelphia, Pennsylvania, United States
Scripps Clinic & Research Foundation
🇺🇸La Jolla, California, United States
Hôpital de l'Archet Pôle Digestif
🇫🇷Nice Cedex 3, France
Hamilton Health Sciences Centre
🇨🇦Hamilton, Ontario, Canada
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Hospital Universitario de Bellvitge
🇪🇸Barcelona, Spain
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 Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Critical Care Research, Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada
University Health Network - Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Polyclinic Family and Specialty Medicine Facility
🇨🇦North York, Ontario, Canada
Rigshospitalet - Abdominalcentret, Hepatologisk Kilinik A
🇩🇰København, Denmark
Hôpital Beaujon
🇫🇷Clichy, France
Med. Klinik m.S. Hepatologie und Gastroenterologie
🇩🇪Berlin, BE, Germany
Israelitisches Krankenhaus
🇩🇪Hamburg, HH, Germany
Policlinico Sant'Orsola - Malpighi centro insufficienza intestinale
🇮🇹Bologna, Italy
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, BW, Germany
Azienda Ospedaliera Universitaria S. Giovanni Battista - Le Molinette
🇮🇹Torino, TO, Italy
Azienda Universitaria Policlinico Federico II
🇮🇹Napoli, Italy
Universitair Medisch Centrum St. Radboud
🇳🇱Nijmegen, Netherlands
Wojewodzki Szpital Specjalistyczny im. M. Pirogowa, Pracownia Leczenia Zywieniowego
🇵🇱Lodz, Poland
Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Chirurgii Ogolnej i Transplantacyjnej
🇵🇱Lublin, Poland
St. Mark's Hospital Northwick Park
🇬🇧Harrow, Gt Lon, United Kingdom
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Green Area, Main Hospital Salford Royal Hospitals NHS Foundation Trust
🇬🇧Manchester, Gt Man, United Kingdom
University College Hospital
🇬🇧London, Gt Lon, United Kingdom
Hôpital Croix Rousse Unité de Nutrition Clinique Intensive
🇫🇷Lyon, France
Wojewodzki Szpital Specjalistyczny,
🇵🇱Olsztyn, Poland
Samodzielny Publiczny Szpital Kliniczny im. prof W. Orlowskiego CMKP, Oddzial Kliniczny Zywienia i Chirurgii
🇵🇱Warsaw, Poland
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States