Short Bowel SyndromeNCT04877431
A Study of Teduglutide (Revestive®) in Children, Teenagers and Adults With Short Bowel Disease
An observational study of Short Bowel Syndrome, run by Takeda at 1 site in Argentina.
Trial summary
The main aims of the study are to assess the safety profile of Teduglutide (Revestive®) in people with Short Bowel Disease as well as how well people respond to the treatment with Teduglutide (Revestive®). Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Short Bowel Syndrome
- How many people
- 45 participants
- Where
- 1 siteArgentina
- Study dates
- 5 Nov 2020to 5 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All adult and pediatric participants who are treated with teduglutide according to approved indications.
Who may be able to join
- Adult participants (greater than or equal to [>=] 18 years) or pediatric (>= 1 year and less than [<] 18) with a diagnosis of SBS who are dependent on parenteral support.
- Have received at least one dose of teduglutide according to approved indications.
- Signed the mandatory consent that has been agreed with national regulatory authorities (ANMAT) as applicable.
Who cannot join
- Not Applicable.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Authorization Study to Monitor Efficacy, Effectiveness and Safety of Teduglutide (Revestive®) in Adult and Pediatric Patients With Short Bowel Syndrome in Argentina
The main aims of the study are to assess the safety profile of Teduglutide (Revestive®) in people with Short Bowel Disease as well as how well people respond to the treatment with Teduglutide (Revestive®).
This study is about collecting data only; participants receive Teduglutide (Revestive®) by their doctors according to the clinical practice but not as part of this study. Only standard care information available in the participant's medical records will be reviewed and collected for this study.
Participants do not need to visit their doctor in addition to their normal visits.
- Conditions
- Short Bowel Syndrome
- Medical subject headings
- Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| De Nova Participants | De nova participants who had received teduglutide after marketing authorization will be enrolled in this study and monitored by their physicians according to local clinical practice then followed for 24-weeks unless treatment discontinuation or lost to follow-up. | |
| Legacy Participants | Legacy participants who received teduglutide treatment prior to marketing authorization under expanded access type of program will be enrolled in this study and monitored by their physicians according to local clinical practice then followed for 24-weeks unless treatment discontinuation or lost to follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events of Special Interest (AESI)
AESI will include biliary disorders and cholecystitis; pancreatic disease; cardiovascular adverse events associated with fluid overload; intestinal obstruction; stoma complications; malignancy; gastrointestinal neoplastic growth, including colorectal polys and small bowel neoplasia; adverse events associated with increased absorption of concomitant oral medications; anxiety; injection site reactions and suspected immunogenic reactions (like hypersensitivity or other reactions); embryo-fetal toxicity (assessed through follow up of all pregnancies).
Measured: Up to 24 months
Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. A serious adverse events (SAEs) is any untoward clinical manifestation of signs, symptoms or outcomes (whether considered related to investigational product or not and at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, congenital abnormality/birth defect, an important medical event. Number of participants with AEs including serious and non-serious AEs will be assessed.
Measured: Up to 24 months
Secondary outcomes (3)
Percentage of Participants With Clinical Response at Week 12 and 24
Clinical response will be defined as a 20 percent (%) or more reductions on weekly parenteral support volume.
Measured: Week 12 and 24
Change From Baseline in Weekly Parenteral Support Volume at Week 12 and 24
Parenteral support volume will be assessed at baseline (before treatment), and at Week 12, and 24.
Measured: Baseline, Week 12 and 24
Change From Baseline in Number of Days per Week of Parenteral Support at Week 12 and 24
Change from baseline in number of days per week requiring parenteral support will be assessed at baseline (before treatment), and at Week 12 and 24.
Measured: Baseline, Week 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start5 Nov 2020
- Primary completion5 Jun 2023
- Study completion5 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877431
- Sponsor's protocol ID
- TAK-633-4003
- Status last verified
- Jul 2023
- First submitted
- 4 May 2021
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Authorization Study to Monitor Efficacy, Effectiveness and Safety of Teduglutide (Revestive®) in Adult and Pediatric Patients With Short Bowel Syndrome in Argentina
- ClinicalTrials.gov ID
- NCT04877431
- Acronym / sponsor ID
- TAK-633-4003
- Conditions
- Short Bowel Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 5 Jun 2023 (actual)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aims of the study are to assess the safety profile of Teduglutide (Revestive®) in people with Short Bowel Disease as well as how well people respond to the treatment with Teduglutide (Revestive®).
This study is about collecting data only; participants receive Teduglutide (Revestive®) by their doctors according to the clinical practice but not as part of this study. Only standard care information available in the participant's medical records will be reviewed and collected for this study.
Participants do not need to visit their doctor in addition to their normal visits.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| De Nova Participants | – | –De nova participants who had received teduglutide after marketing authorization will be enrolled in this study and monitored by their physicians according to local clinical practice then followed for 24-weeks unless treatment discontinuation or lost to follow-up. |
| Legacy Participants | – | –Legacy participants who received teduglutide treatment prior to marketing authorization under expanded access type of program will be enrolled in this study and monitored by their physicians according to local clinical practice then followed for 24-weeks unless treatment discontinuation or lost to follow-up. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All adult and pediatric participants who are treated with teduglutide according to approved indications.
Key inclusion criteria (3 listed)
- Adult participants (greater than or equal to [>=] 18 years) or pediatric (>= 1 year and less than [<] 18) with a diagnosis of SBS who are dependent on parenteral support.
- Have received at least one dose of teduglutide according to approved indications.
- Signed the mandatory consent that has been agreed with national regulatory authorities (ANMAT) as applicable.
Key exclusion criteria (1 listed)
- Not Applicable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Adverse Events of Special Interest (AESI)
Time frame: Up to 24 months
AESI will include biliary disorders and cholecystitis; pancreatic disease; cardiovascular adverse events associated with fluid overload; intestinal obstruction; stoma complications; malignancy; gastrointestinal neoplastic growth, including colorectal polys and small bowel neoplasia; adverse events associated with increased absorption of concomitant oral medications; anxiety; injection site reactions and suspected immunogenic reactions (like hypersensitivity or other reactions); embryo-fetal toxicity (assessed through follow up of all pregnancies).
Number of Participants With Adverse Events (AEs)
Time frame: Up to 24 months
An AE is any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. A serious adverse events (SAEs) is any untoward clinical manifestation of signs, symptoms or outcomes (whether considered related to investigational product or not and at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, congenital abnormality/birth defect, an important medical event. Number of participants with AEs including serious and non-serious AEs will be assessed.
3 secondary outcomes
Percentage of Participants With Clinical Response at Week 12 and 24
Time frame: Week 12 and 24
Change From Baseline in Weekly Parenteral Support Volume at Week 12 and 24
Time frame: Baseline, Week 12 and 24
Change From Baseline in Number of Days per Week of Parenteral Support at Week 12 and 24
Time frame: Baseline, Week 12 and 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Short Bowel Syndrome, run by Takeda at 1 site in Argentina.
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 3 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 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Participants With Adverse Events of Special Interest (AESI) (time frame: Up to 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?
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 19 Jul 2023.