Short Bowel SyndromePhase 3NCT00930644
Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)
A Phase 3 study testing teduglutide in people with Short Bowel Syndrome, run by Shire at 23 sites in 9 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Short Bowel Syndrome
- What is being tested?
- teduglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 23 sitesin 9 countries
- Study dates
- 21 Sep 2009to 24 Jan 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- must have completed 24 weeks of dosing of the CL0600-020 study
Who cannot join
- none
Trial locations and contacts
23 sites in 9 countries.
23 sites in 9 countries
United States6 sites
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Scripps Clinic & Research Foundation
La Jolla, California, 92037
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Mount Sinai Medical Center
New York, New York, 10029
University of Pennslyvania
Philadelphia, Pennsylvania, 19104
University Of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Poland4 sites
Wojewodzki Szpital Specjalistyczny im. M. Pirogowa, Pracownia Leczenia Zywieniowego
Lodz, 90-531
Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Chirurgii Ogolnej i Transplantacyjnej
Lublin, 20-090
Pracownia Żywienia Klinicznego
Olsztyn, 10-651
Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP
Warsaw, 00-416
Canada3 sites
Royal Alexandra Hospital
Edmonton, Alberta, T5H 4B9
St. Michael's Hospital
Toronto, Ontario, M5B1W8
University Health Network - Toronto General Hospital
Toronto, Ontario, M5G 2N2
Germany2 sites
Med. Klinik m.S. Hepatologie und Gastroenterologie
Berlin, State of Berlin, 13353
Universitaetsklinikum Tuebingen Medizinische Klinik I
Tübingen, Baden-Wurttemberg, 72076
Spain2 sites
Hospital Universitario de Bellvitge
Barcelona, 08907
Hospital Universitario 12 de Octubre
Madrid, 28041
United Kingdom2 sites
St. Marks Hospital
Harrow, HA13UJ
University College London Hospital
London, WC1E 6DB
About this study
Official title: A Long-Term, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition Dependent Short Bowel Syndrome
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.
Read the detailed description
Some people with SBS need to infuse parenteral nutrition (PN) in order to live. Although PN can save lives, it can lead to some serious side effects such as infection or liver damage. The risk for those effects increases the longer people are on PN.
Teduglutide is an investigative medicine being evaluated as a possible treatment for people with PN-dependent 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. We want to see if teduglutide can help decrease the amount of PN needed because the body is doing a better job of taking up what it eats and drinks. We also want to find out how safe teduglutide is and record any side effects.
- Conditions
- Short Bowel Syndrome
- Being tested
- teduglutide
- Keywords
- short bowel syndrome, parenteral nutrition, PN, HPN, TPN, SBS
- Medical subject headings
- Short Bowel Syndrome, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
teduglutideDrug
Also called Gattex
0.05 mg/kg/day subcutaneously taken once per day for 24 months
| Study group | Role | What they receive |
|---|---|---|
| teduglutide | Experimental | 0.05 mg/kg/day Receives: Drug: teduglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in PN/IV Volume by Visit
The mean change from baseline in weekly PN.IV volume in percent change is shown by visit.
Measured: 24 months
Absolute Change in PN/IV Volume by Visit
The mean change from baseline in weekly PN.IV volume in Liters is shown by visit.
Measured: 24 months
Secondary outcomes (1)
Number of Subjects Achieving PN/IV Reduction
The number of subjects who achieve at least 1-, 2-, and 3-day reductions in PN/IV per Week.
Measured: 24 Months or Last Dosing Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study start21 Sep 2009
- Primary completion24 Jan 2013
- Study completion24 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nycomed Germany GmbH
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930644
- Sponsor's protocol ID
- CL0600-021
- Other IDs
- 2009-011679-65, 2009
- Status last verified
- Jun 2021
- First submitted
- 26 Jun 2009
- Last updated
- 11 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Jeppesen PB, Sanguinetti EL, Buchman A, Howard L, Scolapio JS, Ziegler TR, Gregory J, Tappenden KA, Holst J, Mortensen PB. Teduglutide (ALX-0600), a dipeptidyl peptidase IV resistant glucagon-like peptide 2 analogue, improves intestinal function in short bowel syndrome patients. Gut. 2005 Sep;54(9):1224-31. doi: 10.1136/gut.2004.061440.
PubMed 16099790Pape UF, Iyer KR, Jeppesen PB, Kunecki M, Pironi L, Schneider SM, Seidner DL, Lee HM, Caminis J. Teduglutide for the treatment of adults with intestinal failure associated with short bowel syndrome: pooled safety data from four clinical trials. Ther Adv Gastroenterol. 2020 Apr 20;13:1756284820905766. doi: 10.1177/1756284820905766. eCollection 2020.
PubMed 32341691
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition Dependent Short Bowel Syndrome
- ClinicalTrials.gov ID
- NCT00930644
- Acronym / sponsor ID
- CL0600-021
- Conditions
- Short Bowel Syndrome
- Keywords
- short bowel syndrome, parenteral nutrition, PN, HPN, TPN, SBS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Collaborators
- Nycomed Germany GmbH
- Study start
- 21 Sep 2009 (actual)
- Primary completion
- 24 Jan 2013 (actual)
- Study completion
- 24 Jan 2013 (actual)
- First posted
- 30 Jun 2009 (estimated)
- Results
- Posted 24 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Some people with SBS need to infuse parenteral nutrition (PN) in order to live. Although PN can save lives, it can lead to some serious side effects such as infection or liver damage. The risk for those effects increases the longer people are on PN.
Teduglutide is an investigative medicine being evaluated as a possible treatment for people with PN-dependent 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. We want to see if teduglutide can help decrease the amount of PN needed because the body is doing a better job of taking up what it eats and drinks. We also want to find out how safe teduglutide is and record any side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| teduglutide | Experimental | Drug: teduglutide0.05 mg/kg/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- must have completed 24 weeks of dosing of the CL0600-020 study
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| teduglutideAlso: Gattex0.05 mg/kg/day subcutaneously taken once per day for 24 months | Drug | teduglutide |
Primary outcome
Percent Change in PN/IV Volume by Visit
Time frame: 24 months
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
The mean change from baseline in weekly PN.IV volume in Liters is shown by visit.
1 secondary outcome
Number of Subjects Achieving PN/IV Reduction
Time frame: 24 Months or Last Dosing Visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16099790Jeppesen PB, Sanguinetti EL, Buchman A, Howard L, Scolapio JS, Ziegler TR, Gregory J, Tappenden KA, Holst J, Mortensen PB. Teduglutide (ALX-0600), a dipeptidyl peptidase IV resistant glucagon-like peptide 2 analogue, improves intestinal function in short bowel syndrome patients. Gut. 2005 Sep;54(9):1224-31. doi: 10.1136/gut.2004.061440.
- Derived from this study: PubMed 32341691Pape UF, Iyer KR, Jeppesen PB, Kunecki M, Pironi L, Schneider SM, Seidner DL, Lee HM, Caminis J. Teduglutide for the treatment of adults with intestinal failure associated with short bowel syndrome: pooled safety data from four clinical trials. Ther Adv Gastroenterol. 2020 Apr 20;13:1756284820905766. doi: 10.1177/1756284820905766. eCollection 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
23 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing teduglutide in people with Short Bowel Syndrome, run by Shire at 23 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Poland, Canada, France, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in PN/IV Volume by Visit (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00930644, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.