Short Bowel SyndromePhase 3NCT03596164

An Extension Study of Teduglutide in Japanese Participants With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004

A Phase 3 study testing Teduglutide, Syringe and Needle in people with Short Bowel Syndrome, run by Takeda at 5 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this clinical study is to evaluate the long-term safety and efficacy of teduglutide in Japanese participants with PN/IV (parenteral nutrition/intravenous)-dependent SBS (short bowel syndrome) who completed SHP633-306 or who were in the extension phase of the TED-C14-004 (NCT02340819) study. Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Short Bowel Syndrome
What is being tested?: Teduglutide, Syringe and Needle
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 5 sitesJapan
Study dates: 9 Jul 2018to 13 Jan 2022
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 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Participants who meet all of the following criteria will be enrolled in this study:
Ability to voluntarily provide written, signed, and informed consent to participate in the study.
Completion of the SHP633-306 study or participation in TED-C14-004 (NCT02340819) Stage 3 or Stage 4.
Females of childbearing potential must agree to comply with the contraceptive requirements of the protocol.
An understanding, ability, and willingness to fully comply with study procedures and restrictions.

Who cannot join

There are no exclusion criteria for this study.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Japan5 sites

Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551
Hyogo College of Medicine Hospital
Hyōgo, 663-8501
Tohoku University Hospital
Miyagi-Ken, 980-8574
Osaka University Hospital
Osaka, 565-0871
Yokohama Municipal Citizen's Hospital
Yokohama, 240-8555

Other trials in Japan

About this study

Official title: An Open-Label, Extension Study of Teduglutide in Japanese Subjects With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004

Conditions: Short Bowel Syndrome
Being tested: Teduglutide, Syringe, Needle, Vial Adapter for Device
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.

TeduglutideDrug
Teduglutide 0.05 mg/kg SC injection will be administered once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm.
SyringeDevice
Teduglutide will be administered using syringe. Syringe is approved for use in Japan by PMDA.
NeedleDevice
Teduglutide will be administered using needle. Needle is approved for use in Japan by PMDA.
Vial Adapter for DeviceDevice
Vial adapter for device is approved for use in Japan by PMDA.

Study groups in NCT03596164
Study group	Role	What they receive
Teduglutide 0.05 mg	Experimental	Participants will receive Teduglutide 0.05 milligram per kilogram (mg/kg) subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm until Teduglutide is commercially available, the participant's participation in this study is discontinued, or the study is discontinued. Receives: Drug: Teduglutide; Device: Syringe; Device: Needle; Device: Vial Adapter for Device

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Demonstrated at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume
The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values)*7. Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Measured: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Change From Baseline in Weekly PS Volume
The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values)*7. Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Measured: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Percent Change From Baseline in Weekly PS Volume
The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values)*7. Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Measured: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Number of Participants Who Were Completely Weaned Off PS at End of Study (EOS)
Measured: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)
Change From Baseline in Days Per Week of PS
Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Measured: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Change From Baseline in Plasma Citrulline Levels
Plasma citrulline was measured as an assessment of enterocyte mass. Plasma samples were analyzed using a validated high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Measured: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Measured: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values
Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Measured: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements
Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Measured: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Number of Participants With Clinically Significant Change From Baseline in Laboratory Values
Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Measured: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Number of Participants Who Reported Positive Specific Antibodies to Teduglutide at EOS
Measured: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)
Change From Baseline in 48-Hour Urine Output
Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Measured: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Number of Participants With Clinically Significant Change From Baseline in Body Weight Measurements
Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Measured: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Number of Participants With Clinically Significant Change From Baseline in BMI
Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Measured: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Number of Participants With Clinically Significant Colonoscopy/Sigmoidoscopy Results
Measured: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jul 201813 Jan 2022

First posted23 Jul 2018
Study start9 Jul 2018
Primary completion13 Jan 2022
Study completion13 Jan 2022

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.
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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03596164
Sponsor's protocol ID: SHP633-307
Status last verified: Feb 2023
First submitted: 28 Jun 2018
Last updated: 15 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites, …).

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Short Bowel Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Extension Study of Teduglutide in Japanese Subjects With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004
ClinicalTrials.gov ID: NCT03596164
Acronym / sponsor ID: SHP633-307
Conditions: Short Bowel Syndrome
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 9 Jul 2018 (actual)
Primary completion: 13 Jan 2022 (actual)
Study completion: 13 Jan 2022 (actual)
First posted: 23 Jul 2018 (actual)
Results: Posted 15 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Teduglutide 0.05 mg	Experimental	Drug: Teduglutide, Device: Syringe, Device: Needle, Device: Vial Adapter for DeviceParticipants will receive Teduglutide 0.05 milligram per kilogram (mg/kg) subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm until Teduglutide is commercially available, the participant's participation in this study is discontinued, or the study is discontinued.

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Ability to voluntarily provide written, signed, and informed consent to participate in the study.
Completion of the SHP633-306 study or participation in TED-C14-004 (NCT02340819) Stage 3 or Stage 4.
Females of childbearing potential must agree to comply with the contraceptive requirements of the protocol.
An understanding, ability, and willingness to fully comply with study procedures and restrictions.

Key exclusion criteria (1 listed)

There are no exclusion criteria for this study.

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
TeduglutideTeduglutide 0.05 mg/kg SC injection will be administered once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm.	Drug	Teduglutide 0.05 mg
SyringeTeduglutide will be administered using syringe. Syringe is approved for use in Japan by PMDA.	Device	Teduglutide 0.05 mg
NeedleTeduglutide will be administered using needle. Needle is approved for use in Japan by PMDA.	Device	Teduglutide 0.05 mg
Vial Adapter for DeviceVial adapter for device is approved for use in Japan by PMDA.	Device	Teduglutide 0.05 mg

Primary outcome

Number of Participants Who Demonstrated at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume
Time frame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values)*7. Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Change From Baseline in Weekly PS Volume
Time frame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values)*7. Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Percent Change From Baseline in Weekly PS Volume
Time frame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values)*7. Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Number of Participants Who Were Completely Weaned Off PS at End of Study (EOS)
Time frame: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)
Change From Baseline in Days Per Week of PS
Time frame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Change From Baseline in Plasma Citrulline Levels
Time frame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Plasma citrulline was measured as an assessment of enterocyte mass. Plasma samples were analyzed using a validated high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values
Time frame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements
Time frame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Number of Participants With Clinically Significant Change From Baseline in Laboratory Values
Time frame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Number of Participants Who Reported Positive Specific Antibodies to Teduglutide at EOS
Time frame: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)
Change From Baseline in 48-Hour Urine Output
Time frame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Number of Participants With Clinically Significant Change From Baseline in Body Weight Measurements
Time frame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Number of Participants With Clinically Significant Change From Baseline in BMI
Time frame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Baseline data refer to the baseline of core studies (SHP633-306 [NCT03663582] or TED-C14-004 [NCT02340819]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Number of Participants With Clinically Significant Colonoscopy/Sigmoidoscopy Results
Time frame: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)

Results and safety

Results posted to the registry on 15 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SHP633-306: Teduglutide 0.05 mg/kg	4	3
TED-C14-004: Teduglutide 0.05 mg/kg	7	6

Primary outcome: Number of Participants Who Demonstrated at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume

Time frame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study). Count of participants. Unit: Participants

Measure	SHP633-306: Teduglutide 0.05 mg/kg n = 4	TED-C14-004: Teduglutide 0.05 mg/kg n = 7
Value	3	5

Population analysed: The safety population included all enrolled participants in the study.

Primary outcome: Change From Baseline in Weekly PS Volume

Time frame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study). Mean (Standard Deviation). Unit: liter per week (L/Week)

Measure	SHP633-306: Teduglutide 0.05 mg/kg n = 4	TED-C14-004: Teduglutide 0.05 mg/kg n = 7
Value	-7.45 (7.908)	-8.67 (7.450)

Population analysed: The safety population included all enrolled participants in the study.

Primary outcome: Percent Change From Baseline in Weekly PS Volume

Time frame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study). Mean (Standard Deviation). Unit: percent change

Measure	SHP633-306: Teduglutide 0.05 mg/kg n = 4	TED-C14-004: Teduglutide 0.05 mg/kg n = 7
Value	-49.55 (41.411)	-52.52 (39.828)

Population analysed: The safety population included all enrolled participants in the study.

Primary outcome: Number of Participants Who Were Completely Weaned Off PS at End of Study (EOS)

Time frame: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months). Count of participants. Unit: Participants

Measure	SHP633-306: Teduglutide 0.05 mg/kg n = 4	TED-C14-004: Teduglutide 0.05 mg/kg n = 7
Value	1	2

Population analysed: The safety population included all enrolled participants in the study.

Adverse events

Time frame: TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SHP633-306: Teduglutide 0.05 mg/kg	3 of 4 (75%)	4 of 4 (100%)	1 of 4
TED-C14-004: Teduglutide 0.05 mg/kg	4 of 7 (57.1%)	7 of 7 (100%)	0 of 7
Total Participants	7 of 11 (63.6%)	11 of 11 (100%)	1 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain more information on the study, click here/on this linkLink provided by the sponsor.
Individual participant dataSharing planned: No. De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites, …).

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
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Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition
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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

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Teduglutide, Syringe and Needle in people with Short Bowel Syndrome, run by Takeda at 5 sites in Japan.

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 5 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 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Japan. 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 15 Mar 2023). 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 Participants Who Demonstrated at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume (time frame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)). The study lists 15 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 NCT03596164.

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 15 Mar 2023.