Clinical Trial: Safety and Efficacy Study of Teduglutide in Subjects with Short Bowel Syndrome


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Sponsored by:	NPS Allelix Corp.
Information provided by:	NPS Allelix Corp.

Condition	Treatment or Intervention	Phase
Short Bowel Syndrome Parenteral Nutrition	Drug: Teduglutide	Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Study of the Efficacy and Safety of Teduglutide in Subjects with Parenteral Nutrition-Dependent Short Bowel Syndrome

Teduglutide is an analog of glucagon-like peptide 2 (GLP-2), a naturally occurring hormone that regulates the growth, proliferation, and maintenance of cells lining the gastrointestinal tract. Teduglutide has been shown in animal studies and previous human clinical trials to increase the size and number of these cells, thereby increasing the absorptive surface area of the intestines.

The multicenter, double-blind, international Phase III trial will randomly assign approximately 80 patients to receive daily subcutaneous injections of 0.05 milligrams or 0.10 milligrams of teduglutide per kilogram of body weight, or a placebo. Dosing will continue for a period of six months. The primary endpoint in the study is a reduction in the use of intravenous feeding, which is often required to sustain life in patients with SBS.

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

Inclusion Criteria:

Men and women, aged 18 years of age or older at the time of signing the informed consent form (ICF)
SBS as a result of major intestinal resection resulting in at least 12 months intravenous feeding
Body weight must be less than 90 kg
At baseline, subjects must require PN treatment to meet their caloric or electrolyte needs due to ongoing malabsorption at least 3 times weekly and to be on a stable PN regimen for 4 weeks before dosing
Body mass index (BMI) 18 to 27 kg/m2
Adequate hepatic and renal function

Exclusion Criteria:

History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state
History of alcohol or drug abuse (within previous year)
Participation in a clinical study within 30 days prior to signing the ICF, or concurrent participation in any clinical study
Clinically significant laboratory abnormalities at the time of randomization
Previous use of teduglutide (ALX-0600)
Prior use of native GLP-2 within 3 months of screening visit
Hospital admission within 1 month prior to screening visit
Pregnant or lactating women
Any condition or circumstance, which in the investigator’s opinion would put the subject at any undue risk, prevent completion of the study, or interfere with analysis of the study results.
Presence of excluded disease: Radiation enteritis, Scleroderma, Celiac disease, Refractory/Tropical sprue, Pseudo-obstruction, Active inflammatory bowel disease (IBD), Pre-malignant/malignant change in colonoscopy biopsy or polypectomy, Surgery scheduled within the time frame of the study, Human immunodeficiency virus (HIV) positive test, Immunological disorders, Possible allergies to teduglutide or its constituents, Significant, active, uncontrolled, untreated systemic diseases

District of Columbia
Georgetown University, Washington, District of Columbia, 20007, United States; Recruiting

Leslie Broseker 202-444-7397
Thomas M. Fishbein, MD, Principal Investigator

Georgia
Emory University Hospital, Atlanta, Georgia, 30322, United States; Not yet recruiting

Ellen Katz, RN 404-727-3030
Thomas R. Ziegler, MD, Principal Investigator

Illinois
Northwestern Center for Clinical Research, Chicago, Illinois, 60611, United States; Recruiting

Anita Wallin, RN 312-695-4015
Alan Buchman, MD, MSPH, Principal Investigator

Kansas
University of Kansas Medical Center, Kansas City, Kansas, 66160, United States; Recruiting

Marilyn Weckbaugh, RN 913-588-1315
Paul R. Schloerb, MD, PhD, Principal Investigator

Nebraska
University of Nebraska Medical Center, Omaha, Nebraska, 68198, United States; Recruiting

Irene Akromis, RN 402-559-8528
John K DiBaise, MD, PhD, Principal Investigator

New York
Albany Medical Center, Albany, New York, 12208, United States; Recruiting

Cynthia Morvillo, RN 518-262-6330
Lyn Howard, MD, FRCP, FACP, Principal Investigator

University of Rochester Medical Center, Rochester, New York, 14642, United States; Recruiting

Carla Caves 585-275-0803
Harry Sax, MD, Principal Investigator

Ohio
The Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States; Not yet recruiting

Amy Knesebeck, RN 216-444-8539
Douglas L. Seidner, MD, PhD, Principal Investigator

Pennsylvania
University of Pennsylvania - Penn Nursing, Philadelphia, Pennsylvania, 19104, United States; Not yet recruiting

Julie Madaras 215-898-3917
Charlene Compher, PhD, RD, FADA, CNSD, Principal Investigator

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, 15213, United States; Recruiting

Brenda Owens, CRNP 412-648-9449
Stephen O'Keefe, MD, PhD, Principal Investigator

Rhode Island
Rhode Island Hospital, Providence, Rhode Island, 02903, United States; Recruiting

Marion Winkler, MS, RD, LDN 401-444-4296
Jorge Albina, MD, Principal Investigator

Tennessee
Vanderbilt Center for Human Nutrition, Nashville, Tennessee, 37212, United States; Recruiting

Alice Buchanan 615-936-1288
Sattar Hadi, MD, PhD, Principal Investigator

Belgium
l'Hôpital Erasme, Brussels, 1070, Belgium; Recruiting

Nathalie Severs, RN 32.2.555.44.55
André Van Gossum, MD, PhD, Principal Investigator

Canada, Alberta
Royal Alexandra Hospital, Edmonton, Alberta, T5H4B9, Canada; Recruiting

Daphne Meyer, RN 780-429-3050
Leah Gramlich, MD, FRCPC, Principal Investigator

Canada, British Columbia
St. Paul's Hospital, Vancouver, British Columbia, V6Z1Y6, Canada; Recruiting

Sarah Patterson, BA, MA 604-682-2344 Ext. 62715
Robert Enns, MD, Principal Investigator

Canada, Ontario
Toronto General Hospital, Toronto, Ontario, M5G2C4, Canada; Recruiting

Olivia Saqui 416-340-4018
Johane Allard, MD, FRCP, Principal Investigator

St. Michael's Hospital, Toronto, Ontario, M5B1W8, Canada; Not yet recruiting

Tracey Pignatiello, BSCN 416-864-5388
Khursheed N. Jeejeebhoy, MD, MGGS, PhD, FRCPC, Principal Investigator

Denmark
Rigshospitalet, University of Copenhagen, Copenhagen, 2100, Denmark; Recruiting

Palle B. Jeppensen, MD, PhD 45.35.45.21.52
Per Brøbech Mortensen, MD, PhD, Principal Investigator

France
Hôpital Edouard Herriot, Lyon, 69437, France; Not yet recruiting

Cécile Chambrier, MD 33.0.4.72.11.76.13
Cécile Chambrier, MD, Principal Investigator

Hôpital de la Croix-Rousse, Lyon, 69317, France; Not yet recruiting

Michèle Gérard-Boncompain, MD 33.4.72.07.17.62
Michèle Gérard-Boncompain, MD, Principal Investigator

Hôpital Lariboisière, Paris, 75475, France; Recruiting

Bernard Messing, MD 33.1.49.95.25.78
Bernard Messing, MD, Principal Investigator

Hôpital Claude-Huriez, Lille, 59037, France; Recruiting

David Seguy, MD 33.3.20.44.53.43
David Seguy, MD, Principal Investigator

Germany
Charité University Hospital, Berlin, 10117, Germany; Not yet recruiting

Wulf Breuel, MD 49.30.450.522.033
Paul Thul, MD, OA, PD, Principal Investigator

Netherlands
Academic Medical Center, Amsterdam, 1100 DD, Netherlands; Recruiting

Mireille Serlie, MD 31.20.566.6071
Hans P Sauerwein, MD, PhD, Principal Investigator

Poland
Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP, Warsaw, 00-416, Poland; Recruiting

Krystyna Majewska 48.22.622.76.18
Omidi Mohammed, MD
Marek Pertkiewicz, MD, PhD, Principal Investigator

United Kingdom
St. Mark's Hospital, Harrow, HA13UJ, United Kingdom; Recruiting

Katharina Wallis, MD 44.0.208.235.4016
Alastair Forbes, MD, FRCP-GMC, Principal Investigator

United Kingdom, Greater Manchester
Hope Hospital, Salford, Greater Manchester, M68HD, United Kingdom; Recruiting

Kay Davis 44.161.206.5148
Jonathon Shaffer, MD, BS, Principal Investigator