Loading clinical trials...

Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A 24-Week Study of the Efficacy and Safety of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome

NCT00798967•Shire

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+7 more criteria

Locations (35)

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

Key Dates

Start Date

November 25, 2008

Primary Completion Date

January 25, 2011

Completion Date

January 25, 2011

Last Updated

June 3, 2021

Enrollment

ACTUAL participants

Conditions

Short Bowel Syndrome

Interventions

teduglutide

DRUG

placebo

DRUG

Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

NCT07197944

Short Bowel Syndrome

View study

RECRUITING

A Survey to Assess Participants' and Physicians' Knowledge When Using GATTEX (Knowledge Assessment Survey)

NCT05561647

Short Bowel Syndrome (SBS)

View study

RECRUITINGPHASE3

A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome

NCT06973304

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 3, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

A Survey to Assess Participants' and Physicians' Knowledge When Using GATTEX (Knowledge Assessment Survey)

A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome

A 90 Day Observational Study as an Extension to the Phase 3,Open Labeled Exploratory Study of RELiZORB

Registry for Participants With Short Bowel Syndrome

Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition