Current partner codePEPTIDESDE
NCT00081458·Phase 3·INTERVENTIONAL

Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome

Status

Completed

Phase

Phase 3

Enrollment

84

Locations

32

Results

Posted

Publications

6

Study summary

What the protocol is testing.

The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS).

Full detailed description

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.

Interventions

Treatment arms and agents.

DRUG

Placebo

placebo injectable subcutaneously daily into thigh or abdomen

DRUG

Teduglutide 0.05 mg/kg/d

Teduglutide 0.05 mg/kg/d daily injectable subcutaneously into the thigh or abdomen

DRUG

Teduglutide 0.1 mg/kg/d

Teduglutide 0.1 /g/kg/d daily injection subcutaneously into thigh or abdomen

Timeline

From registration to results.

  1. First posted

    Apr 14, 2004

  2. Study start

    May 25, 2004

  3. Primary completion

    Jul 6, 2007

  4. Study completion

    Jul 6, 2007

  5. Results posted

    Jul 15, 2013

  6. Registry updated

    Jun 9, 2021

Outcomes

What the study measures.

Primary outcomes

A Graded Response Score in Parenteral Nutrition (PN) Reduction

Time frame · 6 months

The intensity of the response relied on a reduction from Baseline in weekly parenteral nutrition (PN) volume (minimum reduction of 20% and a maximum of 100%). Duration of the response incorporated responses at Weeks(Wk) 16-20 and at Wk20-24. Zero (0 - lowest) assigned if \<20% reduction at Wk20-24 and reduction at Wk16-20 of \< 20%, 20-39%, or \>=40%. One (1) assigned if reduction of 20-39% at Wk20-24 but \< 20% at Wk16-20. Two(2) assigned if reductions of 40-99% at Wk20-24 AND \<20% at Wk16-20 OR 20-39% at Wk20-24 AND 20-39% at Wk16-20. Three (3) assigned if reductions of 100% at Wk20-24 AND \<20% at Wk16-20 OR 40-99% at Wk20-24 AND 20-39% at Wk16-20 OR 20-39% at Wk20-24 AND \>=40% at Wk16-20. Four (4) assigned if reductions of 100% at Wk20-24 AND 20-39% at Wk16-20 OR 40-99% at Wk20-24 AND \>=40% at Wk16-20.

Secondary outcomes

Number of Subjects Achieving Binary Response at Week 20, Maintained at Week 24

Time frame · 6 months of treatment

An efficacy responder was defined as achieving at least a 20% reduction from Baseline to Week 20 and maintained at Week 24 in weekly actual PN infusion volume.

Eligibility

Who can take part.

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

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

Study locations

32 registered sites.

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

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Georgetown University

Washington D.C., District of Columbia, United States

Emory University Hospital

Atlanta, Georgia, United States

Northwestern Center for Clinical Research

Chicago, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Albany Medical Center

Albany, New York, United States

Mount Sinai School of Medicine

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

University of Pennsylvania - Penn Nursing

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Medical University of South Carolina

Charleston, South Carolina, United States

l'Hôpital Erasme

Brussels, Belgium

Royal Alexandra Hospital

Edmonton, Alberta, Canada

St. Paul's Hospital

Vancouver, British Columbia, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Rigshospitalet, University of Copenhagen

Copenhagen, Denmark

Hôpital Claude-Huriez

Lille, France

Hôpital de la Croix-Rousse

Lyon, France

Hôpital Edouard Herriot

Lyon, France

Hôpital Beaujon

Paris, France

Related trials

More studies on Teduglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.