Reduction of Parenteral Nutrition and Hydration Support and Safety With Long-Term Teduglutide Treatment in Patients With Short Bowel Syndrome-Associated Intestinal Failure: STEPS-3 Study.

Seidner DL, Fujioka K, Boullata JI, Iyer K, Lee HM, Ziegler TR

Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition15 May 2018Cited by 66 (Europe PMC)

PMID29761915DOI10.1002/ncp.10092PepBankPUB-29761915

Publisher page PubMedAsk about this study

Jump to 9 results

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study9

9 results from studies that gave the peptide. 9 results from people.

01HumanNon-randomized trialEfficacy outcome
In STEPS-3, 2 SBS-IF patients achieved PS independence during teduglutide treatment.
In plain wordsIn STEPS-3, two SBS-IF patients achieved independence from support during teduglutide treatment.
Peptide
Teduglutide
Outcome
Not applicableNew PS independence
Study
n = 14
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.05 mg/kg/dayAs given in this study (human).
Measurements
Patients achieving PS independence
2 patients
STEPS-3 teduglutide-treated, of 14 enrolled
Source sentences
Summary
Two patients achieved PS independence; 2 additional patients who achieved independence in STEPS-2 maintained enteral autonomy throughout STEPS-3.
2 context sentences(design, population, supporting numbers)
Summary · context
STEPS-3 (NCT01560403), a 1-year, open-label extension study in patients with SBS-IF who completed STEPS-2, further monitored the safety and efficacy of TED (0.05 mg/kg/day).
Summary · context
Baseline was the start of TED treatment, in either STEPS or STEPS-2.
Report a problemFND-2976191505
02HumanNon-randomized trialSafety outcome
In STEPS-3, all teduglutide-treated SBS-IF patients reported at least one treatment-emergent adverse event.
In plain wordsIn STEPS-3, all teduglutide-treated patients reported at least one adverse event during treatment.
Peptide
Teduglutide
Outcome
Not applicableTreatment-emergent adverse events
Study
n = 14
Outcome group
Adverse events · Whole body
Studied dose
0.05 mg/kg/dayAs given in this study (human).
Measurements
Minimum treatment-emergent adverse events per patient
≥ 1 events
All STEPS-3 patients
Source sentences
Summary
All patients reported ≥1 treatment-emergent adverse event (TEAE); 3 patients had TEAEs that were reported as treatment related.
2 context sentences(design, population, supporting numbers)
Summary · context
STEPS-3 (NCT01560403), a 1-year, open-label extension study in patients with SBS-IF who completed STEPS-2, further monitored the safety and efficacy of TED (0.05 mg/kg/day).
Summary · context
Baseline was the start of TED treatment, in either STEPS or STEPS-2.
Report a problemFND-2976191507
03HumanNon-randomized trialSafety outcome
In STEPS-3, 3 teduglutide-treated SBS-IF patients had treatment-emergent adverse events reported as treatment related.
In plain wordsIn STEPS-3, three teduglutide-treated patients had adverse events reported as treatment related.
Peptide
Teduglutide
Outcome
Not applicableTreatment-related adverse events
Study
n = 14
Outcome group
Adverse events · Whole body
Studied dose
0.05 mg/kg/dayAs given in this study (human).
Measurements
Patients with treatment-related TEAEs
3 patients
STEPS-3 teduglutide-treated, of 14 enrolled
Source sentences
Summary
All patients reported ≥1 treatment-emergent adverse event (TEAE); 3 patients had TEAEs that were reported as treatment related.
2 context sentences(design, population, supporting numbers)
Summary · context
STEPS-3 (NCT01560403), a 1-year, open-label extension study in patients with SBS-IF who completed STEPS-2, further monitored the safety and efficacy of TED (0.05 mg/kg/day).
Summary · context
Baseline was the start of TED treatment, in either STEPS or STEPS-2.
Report a problemFND-2976191508
04HumanNon-randomized trialSafety outcome
In STEPS-3, no teduglutide-treated SBS-IF patient had a treatment-related treatment-emergent serious adverse event.
In plain wordsIn STEPS-3, no teduglutide-treated patient had a serious adverse event related to treatment.
Peptide
Teduglutide
Outcome
Not applicableTreatment-related serious adverse events
Study
n = 14
Outcome group
Adverse events · Whole body
Studied dose
0.05 mg/kg/dayAs given in this study (human).
Source sentences
Summary
No patient had a treatment-related treatment-emergent serious AE.
2 context sentences(design, population, supporting numbers)
Summary · context
STEPS-3 (NCT01560403), a 1-year, open-label extension study in patients with SBS-IF who completed STEPS-2, further monitored the safety and efficacy of TED (0.05 mg/kg/day).
Summary · context
Baseline was the start of TED treatment, in either STEPS or STEPS-2.
Report a problemFND-2976191509
05HumanNon-randomized trialEfficacy outcome
In SBS-IF patients in the NT/PBO-TED sequence, teduglutide reduced PS volume by 3.9 L/week (SD 2.8, 48%) at the last dosing visit.
In plain wordsIn SBS-IF patients in the NT/PBO-TED sequence, support volume fell from baseline during teduglutide treatment.
Peptide
Teduglutide
Outcome
DecreasePS volume in NT/PBO-TED sequence
Study
n = 9
Comparator
baseline
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.05 mg/kg/day · ≤36 monthsAs given in this study (human).
Measurements
Reduction in parenteral support volume, mean
3.9 L/week
NT/PBO-TED, last dosing visit
Reduction in parenteral support volume, SD
2.8 L/week
NT/PBO-TED
Reduction in parenteral support volume, bracketed value
48%
NT/PBO-TED
Source sentences
Summary
At the last dosing visit, mean (SD) PS was reduced from baseline by 9.8 (14.4 [50%]) and 3.9 (2.8 [48%]) L/week in TED-TED and NT/PBO-TED, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
At the end of STEPS-3, patients treated with TED in both STEPS and STEPS-2 (TED-TED) received TED for ≤42 months, and patients treated with TED only in STEPS-2 (no TED treatment [NT]/PBO-TED) received TED for ≤36 months.
Summary · context
STEPS-3 (NCT01560403), a 1-year, open-label extension study in patients with SBS-IF who completed STEPS-2, further monitored the safety and efficacy of TED (0.05 mg/kg/day).
Summary · context
Baseline was the start of TED treatment, in either STEPS or STEPS-2.
Report a problemFND-2976191502
06HumanNon-randomized trialEfficacy outcome
In SBS-IF patients in the NT/PBO-TED sequence, PS infusions decreased from baseline by 2.1 days per week (SD 2.2).
In plain wordsIn SBS-IF patients in the NT/PBO-TED sequence, infusion days fell from baseline during teduglutide treatment.
Peptide
Teduglutide
Outcome
DecreasePS infusion days in NT/PBO-TED sequence
Study
n = 9
Comparator
baseline
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.05 mg/kg/day · ≤36 monthsAs given in this study (human).
Measurements
Decrease in PS infusions, mean
2.1 days/week
NT/PBO-TED
Decrease in PS infusions, SD
2.2 days/week
NT/PBO-TED
Source sentences
Summary
Mean (SD) PS infusions decreased by 3.0 (4.6) and 2.1 (2.2) days per week from baseline in TED-TED and NT/PBO-TED, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
At the end of STEPS-3, patients treated with TED in both STEPS and STEPS-2 (TED-TED) received TED for ≤42 months, and patients treated with TED only in STEPS-2 (no TED treatment [NT]/PBO-TED) received TED for ≤36 months.
Summary · context
STEPS-3 (NCT01560403), a 1-year, open-label extension study in patients with SBS-IF who completed STEPS-2, further monitored the safety and efficacy of TED (0.05 mg/kg/day).
Summary · context
Baseline was the start of TED treatment, in either STEPS or STEPS-2.
Report a problemFND-2976191504
07HumanNon-randomized trialEfficacy outcome
In SBS-IF patients in the TED-TED sequence, teduglutide reduced PS volume by 9.8 L/week (SD 14.4, 50%) at the last dosing visit.
In plain wordsIn SBS-IF patients in the TED-TED sequence, support volume fell from baseline during teduglutide treatment.
Peptide
Teduglutide
Outcome
DecreasePS volume in TED-TED sequence
Study
n = 5
Comparator
baseline
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.05 mg/kg/day · ≤42 monthsAs given in this study (human).
Measurements
Reduction in parenteral support volume, mean
9.8 L/week
TED-TED, last dosing visit
Reduction in parenteral support volume, SD
14.4 L/week
TED-TED
Reduction in parenteral support volume, bracketed value
50%
TED-TED
Source sentences
Summary
At the last dosing visit, mean (SD) PS was reduced from baseline by 9.8 (14.4 [50%]) and 3.9 (2.8 [48%]) L/week in TED-TED and NT/PBO-TED, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
At the end of STEPS-3, patients treated with TED in both STEPS and STEPS-2 (TED-TED) received TED for ≤42 months, and patients treated with TED only in STEPS-2 (no TED treatment [NT]/PBO-TED) received TED for ≤36 months.
Summary · context
STEPS-3 (NCT01560403), a 1-year, open-label extension study in patients with SBS-IF who completed STEPS-2, further monitored the safety and efficacy of TED (0.05 mg/kg/day).
Summary · context
Baseline was the start of TED treatment, in either STEPS or STEPS-2.
Report a problemFND-2976191501
08HumanNon-randomized trialEfficacy outcome
In SBS-IF patients in the TED-TED sequence, PS infusions decreased from baseline by 3.0 days per week (SD 4.6).
In plain wordsIn SBS-IF patients in the TED-TED sequence, infusion days fell from baseline during teduglutide treatment.
Peptide
Teduglutide
Outcome
DecreasePS infusion days in TED-TED sequence
Study
n = 5
Comparator
baseline
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.05 mg/kg/day · ≤42 monthsAs given in this study (human).
Measurements
Decrease in PS infusions, mean
3 days/week
TED-TED
Decrease in PS infusions, SD
4.6 days/week
TED-TED
Source sentences
Summary
Mean (SD) PS infusions decreased by 3.0 (4.6) and 2.1 (2.2) days per week from baseline in TED-TED and NT/PBO-TED, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
At the end of STEPS-3, patients treated with TED in both STEPS and STEPS-2 (TED-TED) received TED for ≤42 months, and patients treated with TED only in STEPS-2 (no TED treatment [NT]/PBO-TED) received TED for ≤36 months.
Summary · context
STEPS-3 (NCT01560403), a 1-year, open-label extension study in patients with SBS-IF who completed STEPS-2, further monitored the safety and efficacy of TED (0.05 mg/kg/day).
Summary · context
Baseline was the start of TED treatment, in either STEPS or STEPS-2.
Report a problemFND-2976191503
09HumanNon-randomized trialEfficacy outcome
In STEPS-3, 2 teduglutide-treated SBS-IF patients maintained enteral autonomy achieved in STEPS-2 throughout STEPS-3.
In plain wordsIn STEPS-3, two teduglutide-treated patients maintained independence from support achieved in STEPS-2.
Peptide
Teduglutide
Outcome
Not applicableMaintained enteral autonomy
Study
n = 2
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.05 mg/kg/dayAs given in this study (human).
Measurements
Patients maintaining enteral autonomy achieved in STEPS-2
2 patients
STEPS-3 teduglutide-treated
Source sentences
Summary
Two patients achieved PS independence; 2 additional patients who achieved independence in STEPS-2 maintained enteral autonomy throughout STEPS-3.
2 context sentences(design, population, supporting numbers)
Summary · context
STEPS-3 (NCT01560403), a 1-year, open-label extension study in patients with SBS-IF who completed STEPS-2, further monitored the safety and efficacy of TED (0.05 mg/kg/day).
Summary · context
Baseline was the start of TED treatment, in either STEPS or STEPS-2.
Report a problemFND-2976191506

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT01560403

A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021

Shiren = 1421 May 2012 to 23 Jul 2013

Short Bowel Syndrome

Trial page ClinicalTrials.govUpdated 10 Jun 2021

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:37 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

PepBank is a research reference. Talk to a doctor before you use any peptide.