Current partner codePEPTIDESDE
NCT00798967·Phase 3·INTERVENTIONAL

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

Status

Completed

Phase

Phase 3

Enrollment

86

Locations

35

Results

Posted

Publications

8

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

teduglutide

0.05 mg/kg/day sc injection for 24 weeks

DRUG

placebo

Matching daily subcutaneous dose of placebo to teduglutide for 24 weeks

Timeline

From registration to results.

  1. First posted

    Nov 27, 2008

  2. Study start

    Nov 25, 2008

  3. Primary completion

    Jan 25, 2011

  4. Study completion

    Jan 25, 2011

  5. Results posted

    Feb 1, 2012

  6. Registry updated

    Jun 3, 2021

Outcomes

What the study measures.

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

Time frame · 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).

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 * 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 locations

35 registered sites.

Canada · Denmark · France · Germany · Italy · Netherlands · Poland · Spain · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.

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

Publications

Results and literature.

PMID 16099790Jeppesen PB, Sanguinetti EL, Buchman A, Howard L, Scolapio JS, Ziegler TR, Gregory J, Tappenden KA, Holst J, Mortensen PB. Teduglutide (ALX-0600), a dipeptidyl peptidase IV resistant glucagon-like peptide 2 analogue, improves intestinal function in short bowel syndrome patients. Gut. 2005 Sep;54(9):1224-31. doi: 10.1136/gut.2004.061440.PMID 31784300Jeppesen PB, Gabe SM, Seidner DL, Lee HM, Olivier C. Citrulline correlations in short bowel syndrome-intestinal failure by patient stratification: Analysis of 24 weeks of teduglutide treatment from a randomized controlled study. Clin Nutr. 2020 Aug;39(8):2479-2486. doi: 10.1016/j.clnu.2019.11.001. Epub 2019 Nov 9.PMID 29174926Jeppesen PB, Gabe SM, Seidner DL, Lee HM, Olivier C. Factors Associated With Response to Teduglutide in Patients With Short-Bowel Syndrome and Intestinal Failure. Gastroenterology. 2018 Mar;154(4):874-885. doi: 10.1053/j.gastro.2017.11.023. Epub 2017 Nov 22.PMID 27507402Fujioka K, Jeejeebhoy K, Pape UF, Li B, Youssef NN, Schneider SM. Patients With Short Bowel on Narcotics During 2 Randomized Trials Have Abdominal Complaints Independent of Teduglutide. JPEN J Parenter Enteral Nutr. 2017 Nov;41(8):1419-1422. doi: 10.1177/0148607116663481. Epub 2016 Aug 9.PMID 24134154Vipperla K, O'Keefe SJ. Study of teduglutide effectiveness in parenteral nutrition-dependent short-bowel syndrome subjects. Expert Rev Gastroenterol Hepatol. 2013 Nov;7(8):683-7. doi: 10.1586/17474124.2013.842894. Epub 2013 Oct 17.PMID 23587733Jeppesen PB, Pertkiewicz M, Forbes A, Pironi L, Gabe SM, Joly F, Messing B, Loth S, Youssef NN, Heinze H, Berghofer P. Quality of life in patients with short bowel syndrome treated with the new glucagon-like peptide-2 analogue teduglutide--analyses from a randomised, placebo-controlled study. Clin Nutr. 2013 Oct;32(5):713-21. doi: 10.1016/j.clnu.2013.03.016. Epub 2013 Mar 28.PMID 23274148Berghofer P, Fragkos KC, Baxter JP, Forbes A, Joly F, Heinze H, Loth S, Pertkiewicz M, Messing B, Jeppesen PB. Development and validation of the disease-specific Short Bowel Syndrome-Quality of Life (SBS-QoL) scale. Clin Nutr. 2013 Oct;32(5):789-96. doi: 10.1016/j.clnu.2012.12.001. Epub 2012 Dec 12.PMID 22982184Jeppesen PB, Pertkiewicz M, Messing B, Iyer K, Seidner DL, O'keefe SJ, Forbes A, Heinze H, Joelsson B. Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure. Gastroenterology. 2012 Dec;143(6):1473-1481.e3. doi: 10.1053/j.gastro.2012.09.007. Epub 2012 Sep 11.

Primary links

Continue at the source.

Related trials

More studies on Teduglutide.

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