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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name STEPS

NCTNCT00798967 (opens ClinicalTrials.gov in a new tab)Other idCL0600-020Other id2008-006193-15Other id2008

Overview

Status
Completed
Phase
Phase 3
Enrollment
86 participants (actual)
Sponsor
Shire · Industry
Design
Randomized · Quadruple masking
Countries
10 countries

United States, Canada, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom

Start
25 Nov 2008
Primary completion
25 Jan 2011
Completion
25 Jan 2011
First posted
27 Nov 2008 (estimated)
Last update posted
3 Jun 2021
Conditions
Short Bowel Syndrome

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20082009201020112012
  1. Ph 3

    STEPS

    NCT00798967

    25 Nov 2008 to 25 Jan 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • teduglutideDrug
  • placeboDrug

Arms2

  • Experimental

    Teduglutide

    0.05 mg/kg/day sc dose of teduglutide

  • Placebo comparator

    Placebo

    Matching subcutaneous dose of placebo to teduglutide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Responder

    Time frame · Weeks 20 and 24

    Registry description

    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(1)
  1. Absolute Change in PN/I.V. Volume From Baseline to Last Time Point

    Time frame · Week 0 to last visit when data was collected.

    Registry description

    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).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Weeks 20 and 24

Responder

GroupValue (subjects)
Teduglutide27
Placebo13
Secondary and other outcome results(1)
Secondary outcomeMean· Week 0 to last visit when data was collected.

Absolute Change in PN/I.V. Volume From Baseline to Last Time Point

GroupValue (Liters/Week)Spread
Teduglutide-4.283.81
Placebo-2.382.79

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Teduglutide0.05 mg/kg/day subcutaneous (sc) dose of teduglutide–15 / 4235 / 42
PlaceboMatching sc dose of placebo to teduglutide–12 / 4334 / 43

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies6

Studies that cite this trial.

Studies with results

5 studies on this page

Indexing hint: Randomized controlled trial · 2020

1 result

Citrulline correlations in short bowel syndrome-intestinal failure by patient stratification: Analysis of 24 weeks of teduglutide treatment from a randomized controlled study.

Jeppesen et al. 2020Clinical nutrition (Edinburgh, Scotland)cited by 18

PMID 31784300DOI 10.1016/j.clnu.2019.11.001PUB-31784300

Free to read · publisher termsCC BY-NC-ND1 result

Indexing hint: Randomized controlled trial · 2018

4 results

Factors Associated With Response to Teduglutide in Patients With Short-Bowel Syndrome and Intestinal Failure.

Jeppesen et al. 2018Gastroenterologycited by 102

PMID 29174926DOI 10.1053/j.gastro.2017.11.023PUB-29174926

Free to read · publisher termsCC BY-NC-ND4 results

Indexing hint: Randomized controlled trial · 2017

2 results

Patients With Short Bowel on Narcotics During 2 Randomized Trials Have Abdominal Complaints Independent of Teduglutide.

Fujioka et al. 2017JPEN. Journal of parenteral and enteral nutritioncited by 10

PMID 27507402PMC5703028DOI 10.1177/0148607116663481PUB-27507402

CC BY2 results

Indexing hint: Randomized controlled trial · 2013

6 results

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.

Jeppesen et al. 2013Clinical nutrition (Edinburgh, Scotland)cited by 79

PMID 23587733DOI 10.1016/j.clnu.2013.03.016PUB-23587733

Full text at the publisher6 results

Indexing hint: Randomized controlled trial · 2012

5 results

Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure.

Jeppesen et al. 2012Gastroenterologycited by 348

PMID 22982184DOI 10.1053/j.gastro.2012.09.007PUB-22982184

Rights unknown5 results

More studies

1 study on this page

Indexing hint: Clinical trial · 2005

Teduglutide (ALX-0600), a dipeptidyl peptidase IV resistant glucagon-like peptide 2 analogue, improves intestinal function in short bowel syndrome patients.

Jeppesen et al. 2005Gutcited by 353

PMID 16099790PMC1774653DOI 10.1136/gut.2004.061440PUB-16099790

Rights unknown
Source link

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedVipperla 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 24134154
  • DerivedBerghofer 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 23274148

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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