Short Bowel SyndromePhase 3NCT00172185
Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)
A Phase 3 study testing teduglutide 0.05 mg/kg/d and teduglutide 0.10 mg/kg/d in people with Short Bowel Syndrome, run by Shire at 21 sites in 8 countries.
Trial summary
The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide. 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 0.05 mg/kg/d and teduglutide 0.10 mg/kg/d
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 21 sitesin 8 countries
- Study dates
- 10 Jan 2005to 24 Jan 2008
- 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
- At dosing week 24 of protocol CL0600-004 (NCT00081458), subjects will be reviewed for their participation in this study.
- Subjects who meet all of the following criteria can be enrolled in this study:
- Signed and dated informed consent form (ICF) to participate before any study-related procedures are performed
- Completion of protocol CL0600-004 (NCT00081458)
Who cannot join
- History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state
- History of alcohol or drug abuse (within previous year)
- Prior use of native glucagon-like peptide 2 (GLP-2) within 3 months of screening visit
- Pregnant or lactating women
- Any condition or circumstance, which in the investigator's opinion would put the subject at any undue risk, prevent completion of the study, or interfere with analysis of the study results
Trial locations and contacts
21 sites in 8 countries.
21 sites in 8 countries
United States9 sites
Albany Medical Center
Albany, New York, 12208
Emory University Hospital
Atlanta, Georgia, 30322
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Nebraska Medical Center
Omaha, Nebraska, 68198
University of Pennsylvania - Penn Nursing
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Rhode Island Hospital
Providence, Rhode Island, 02903
University of Rochester Medical Center
Rochester, New York, 14642
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259
Canada3 sites
St. Michael's Hospital
Toronto, Ontario, M5B1W8
Toronto General Hospital
Toronto, Ontario, M5G2N2
St. Paul's Hospital
Vancouver, British Columbia, V6Z1Y6
France3 sites
Hôpital Huriez
Lille, 59037
Hôpital de la Croix-Rousse
Lyon, 69317
Hôpital Lariboisière
Paris, 92110
Poland2 sites
Pracownia Żywienia
Olsztyn, 10-561
Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP
Warsaw, 00-416
Netherlands1 site
Academic Medical Center, Department of Endocrinology & Metabolism
Amsterdam, 1100 DD
About this study
Official title: A Study of the Safety and Efficacy of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)
The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.
Read the detailed description
Teduglutide is an analog of naturally occurring human glucagon-like peptide-2 (GLP-2), a peptide secreted by L-cells of the distal intestine. GLP-2 is known to increase intestinal and portal blood flow, and inhibit gastric acid secretion. Teduglutide binds to the glucagon-like peptide-2 receptors located in intestinal subpopulations of enteroendocrine cells, subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric plexus. Activation of these receptors results in the local release of multiple mediators including insulin-like growth factor (IGF)-1, nitric oxide and keratinocyte growth factor (KGF).
This multicenter, double-blind, international, Phase III trial will have a treatment period of 28 weeks. Subjects in this study are those who received teduglutide or placebo in protocol CL0600-004 (NCT00081458). These subjects will receive daily subcutaneous injections of 0.05 milligrams or 0.10 milligrams of teduglutide per kilogram of body weight. Subjects will have visits every 4 to 6 weeks and will be assessed for parenteral nutrition (PN) reduction with a follow-up period of 4 weeks duration for those subjects who do not complete this protocol, or do not enter into the long-term safety extension protocol CL0600-010.
- Conditions
- Short Bowel Syndrome
- Being tested
- teduglutide 0.05 mg/kg/d, teduglutide 0.10 mg/kg/d
- Keywords
- Short Bowel Syndrome, Parenteral Nutrition, SBS, Teduglutide
- 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.
teduglutide 0.05 mg/kg/dDrug
Also called GATTEX
0.05 mg/kg/d subcutaneous injection
teduglutide 0.10 mg/kg/dDrug
Also called GATTEX
0.10 mg/kg/d subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| teduglutide 0.05 mg/kg/d | Experimental | 0.05 mg/kg/d teduglutide subcutaneous injection Receives: Drug: teduglutide 0.05 mg/kg/d |
| teduglutide 0.10 mg/kg/d | Experimental | 0.10 mg/kg/d teduglutide subcutaneous injection Receives: Drug: teduglutide 0.10 mg/kg/d |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Achieving a 20% Reduction at Week 28
For those subjects who received teduglutide (0.05 or 0.10 mg dose) in Study 004 and the same in Study 005, Parenteral Nutrition (PN) Use at Week 28 was compared to the Baseline Visit of Study 004 to calculate the 20% reduction in PN Use. For those subjects who received placebo in Study 004 and either teduglutide 0.05 or 0.10 mg dose in Study 005, PN Use at Week 28 was compared to the use of PN at Week 24 of Study 004 to calculate the 20% reduction in PN Use.
Measured: 28 weeks
Secondary outcomes (1)
Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use
Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use (Responder Status is Yes or No)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study start10 Jan 2005
- Primary completion24 Jan 2008
- Study completion24 Jan 2008
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 (3)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00172185
- Sponsor's protocol ID
- CL0600-005
- Other IDs
- 2004-000439-27, 2004
- Status last verified
- May 2021
- First submitted
- 13 Sep 2005
- Last updated
- 2 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Jeppesen PB, Gilroy R, Pertkiewicz M, Allard JP, Messing B, O'Keefe SJ. Randomised placebo-controlled trial of teduglutide in reducing parenteral nutrition and/or intravenous fluid requirements in patients with short bowel syndrome. Gut. 2011 Jul;60(7):902-14. doi: 10.1136/gut.2010.218271. Epub 2011 Feb 11.
PubMed 21317170O'Keefe SJ, Jeppesen PB, Gilroy R, Pertkiewicz M, Allard JP, Messing B. Safety and efficacy of teduglutide after 52 weeks of treatment in patients with short bowel intestinal failure. Clin Gastroenterol Hepatol. 2013 Jul;11(7):815-23.e1-3. doi: 10.1016/j.cgh.2012.12.029. Epub 2013 Jan 17.
PubMed 23333663Vipperla 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.
PubMed 24134154
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Safety and Efficacy of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)
- ClinicalTrials.gov ID
- NCT00172185
- Acronym / sponsor ID
- CL0600-005
- Conditions
- Short Bowel Syndrome
- Keywords
- Short Bowel Syndrome, Parenteral Nutrition, SBS, Teduglutide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2005 (actual)
- Primary completion
- 24 Jan 2008 (actual)
- Study completion
- 24 Jan 2008 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Posted 23 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.
Detailed description
Teduglutide is an analog of naturally occurring human glucagon-like peptide-2 (GLP-2), a peptide secreted by L-cells of the distal intestine. GLP-2 is known to increase intestinal and portal blood flow, and inhibit gastric acid secretion. Teduglutide binds to the glucagon-like peptide-2 receptors located in intestinal subpopulations of enteroendocrine cells, subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric plexus. Activation of these receptors results in the local release of multiple mediators including insulin-like growth factor (IGF)-1, nitric oxide and keratinocyte growth factor (KGF).
This multicenter, double-blind, international, Phase III trial will have a treatment period of 28 weeks. Subjects in this study are those who received teduglutide or placebo in protocol CL0600-004 (NCT00081458). These subjects will receive daily subcutaneous injections of 0.05 milligrams or 0.10 milligrams of teduglutide per kilogram of body weight. Subjects will have visits every 4 to 6 weeks and will be assessed for parenteral nutrition (PN) reduction with a follow-up period of 4 weeks duration for those subjects who do not complete this protocol, or do not enter into the long-term safety extension protocol CL0600-010.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| teduglutide 0.05 mg/kg/d | Experimental | Drug: teduglutide 0.05 mg/kg/d0.05 mg/kg/d teduglutide subcutaneous injection |
| teduglutide 0.10 mg/kg/d | Experimental | Drug: teduglutide 0.10 mg/kg/d0.10 mg/kg/d teduglutide subcutaneous injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At dosing week 24 of protocol CL0600-004 (NCT00081458), subjects will be reviewed for their participation in this study.
- Signed and dated informed consent form (ICF) to participate before any study-related procedures are performed
- Completion of protocol CL0600-004 (NCT00081458)
Key exclusion criteria (5 listed)
- History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state
- History of alcohol or drug abuse (within previous year)
- Prior use of native glucagon-like peptide 2 (GLP-2) within 3 months of screening visit
- Pregnant or lactating women
- Any condition or circumstance, which in the investigator's opinion would put the subject at any undue risk, prevent completion of the study, or interfere with analysis of the study results
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 |
|---|---|---|
| teduglutide 0.05 mg/kg/dAlso: GATTEX0.05 mg/kg/d subcutaneous injection | Drug | teduglutide 0.05 mg/kg/d |
| teduglutide 0.10 mg/kg/dAlso: GATTEX0.10 mg/kg/d subcutaneous injection | Drug | teduglutide 0.10 mg/kg/d |
Primary outcome
Number of Subjects Achieving a 20% Reduction at Week 28
Time frame: 28 weeks
For those subjects who received teduglutide (0.05 or 0.10 mg dose) in Study 004 and the same in Study 005, Parenteral Nutrition (PN) Use at Week 28 was compared to the Baseline Visit of Study 004 to calculate the 20% reduction in PN Use. For those subjects who received placebo in Study 004 and either teduglutide 0.05 or 0.10 mg dose in Study 005, PN Use at Week 28 was compared to the use of PN at Week 24 of Study 004 to calculate the 20% reduction in PN Use.
1 secondary outcome
Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21317170Jeppesen PB, Gilroy R, Pertkiewicz M, Allard JP, Messing B, O'Keefe SJ. Randomised placebo-controlled trial of teduglutide in reducing parenteral nutrition and/or intravenous fluid requirements in patients with short bowel syndrome. Gut. 2011 Jul;60(7):902-14. doi: 10.1136/gut.2010.218271. Epub 2011 Feb 11.
- Results publication: PubMed 23333663O'Keefe SJ, Jeppesen PB, Gilroy R, Pertkiewicz M, Allard JP, Messing B. Safety and efficacy of teduglutide after 52 weeks of treatment in patients with short bowel intestinal failure. Clin Gastroenterol Hepatol. 2013 Jul;11(7):815-23.e1-3. doi: 10.1016/j.cgh.2012.12.029. Epub 2013 Jan 17.
- Results publication: PubMed 24134154Vipperla 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.
Related trials for Short Bowel Syndrome
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingPhase 3
Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition
Short Bowel Syndrome
Not yet recruitingPhase 2
Efficacy and Safety of TRA16 Administered Orally in Patients With Enteric Hyperoxaluria (EH).
Enteric Hyperoxaluria
RecruitingPhase 3
Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
Short Bowel Syndrome
Active, not recruitingObservational study
Registry for Participants With Short Bowel Syndrome
Short Bowel Syndrome
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
21 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing teduglutide 0.05 mg/kg/d and teduglutide 0.10 mg/kg/d in people with Short Bowel Syndrome, run by Shire at 21 sites in 8 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 4 inclusion and 5 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 2 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 21 sites in United States, Canada, France, Poland, Belgium and 3 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 23 Apr 2013). 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?
Number of Subjects Achieving a 20% Reduction at Week 28 (time frame: 28 weeks). 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 NCT00172185, which also lists 3 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 2 Jun 2021.