Trial · Interventional

CompletedPhase 3Results postedRegistry data

Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)

NCTNCT00930644Other idCL0600-021Other id2009-011679-65Other id2009

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 88 participants (actual)
Sponsor: Shire · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 9 countries
United States, Canada, Denmark, France, Germany, Italy, Poland, Spain, United Kingdom
Start: 21 Sept 2009
Primary completion: 24 Jan 2013
Completion: 24 Jan 2013
First posted: 30 Jun 2009 (estimated)
Last update posted: 11 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

200920102011201220132014

Ph 3
Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)
NCT00930644
21 Sept 2009 to 24 Jan 2013

Registry summary

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

This study is a 2-year open label extension study to collect long term efficacy and safety data from patients who have completed the 24-weeks of study drug dosing in CL0600-020.

Interventions

teduglutideDrug

Arms1

Experimental
teduglutide
0.05 mg/kg/day

Primary outcomes2

Outcomes the sponsor listed as primary.

Percent Change in PN/IV Volume by Visit
Time frame · 24 months
Registry description
The mean change from baseline in weekly PN.IV volume in percent change is shown by visit.
Absolute Change in PN/IV Volume by Visit
Time frame · 24 months
Registry description
The mean change from baseline in weekly PN.IV volume in Liters is shown by visit.

Secondary outcomes(1)

Number of Subjects Achieving PN/IV Reduction
Time frame · 24 Months or Last Dosing Visit
Registry description
The number of subjects who achieve at least 1-, 2-, and 3-day reductions in PN/IV per Week.

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 outcomeMean· 24 months

Percent Change in PN/IV Volume by Visit

Group	Value (percent change)	Spread
NT/TED	-5.35	11.287
PBO/TED	-6.44	11.241
TED/TED	-40.65	21.546

Primary outcomeMean· 24 months

Absolute Change in PN/IV Volume by Visit

Group	Value (Liters)	Spread
NT/TED	-1.05	1.315
PBO/TED	-0.95	1.938
TED/TED	-5.28	3.819

Secondary and other outcome results(1)

Secondary outcomeNumber· 24 Months or Last Dosing Visit

Number of Subjects Achieving PN/IV Reduction

Group	Value (participants)
NT/TED	3
PBO/TED	14
TED/TED	21

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
NT,PBO/TEDNo treatment or placebo in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial	–	32 / 51	49 / 51
TED/TED0.05 mg/kg/day subcutaneously taken once per day for 6 months CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial	–	24 / 37	35 / 37

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

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2020

9 results

Teduglutide for the treatment of adults with intestinal failure associated with short bowel syndrome: pooled safety data from four clinical trials.

Pape et al. 2020Therapeutic advances in gastroenterologycited by 42

PMID 32341691PMC7171995DOI 10.1177/1756284820905766PUB-32341691

Free to read · publisher termsCC BY-NC9 results

Read at source See results (9)

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

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * must have completed 24 weeks of dosing of the CL0600-020 study Exclusion Criteria: * none

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