Short Bowel Syndrome (SBS)NCT07319832
A Study of Teduglutide in Chinese Children and Teenagers With Short Bowel Syndrome
An observational study of Short Bowel Syndrome (SBS), run by Takeda at 4 sites in China.
Trial summary
Short Bowel Syndrome (SBS) is a rare condition that happens when a large part of the bowel (also called intestine) is missing or has been removed because of illness or surgery. In children, SBS means that the intestine cannot absorb enough food, water and important part of food the body needs (called nutrients)… Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Short Bowel Syndrome (SBS)
- How many people
- 12 participants
- Where
- 4 sitesChina
- Study dates
- 5 Mar 2026to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population consists of Chinese pediatric participants with SBS who are dependent on PS.
Who may be able to join
- Children and adolescents greater than or equal to (>=)1 through 17 years of age at Day 1 (D1).
- Documented diagnosis of SBS.
- Received or plan to receive Teduglutide treatment for a minimum of 24 weeks.
- Stable PN/IV support, defined as inability to significantly reduce PN/IV support, usually associated with minimal or no advance in enteral feeds (i.e., 10% or less change in PN or advance in feeds) for at least 3 months prior to D1, as assessed by the investigator. Transient instability for events such as interruption of central access or treatment for sepsis is allowed if the PN/IV support returns to within 10% of baseline prior to the event.
- Informed consent obtained from the patient aged 8 to 17 years and their guardians, while informed consent from the guardians for participants under 8 years old, unless waived by the Institution's Ethics Committee.
Who cannot join
- Participants who are not expected to be able to advance oral or tube feeding regimens.
- Serial Transverse Enteroplasty (STEP) or any other bowel lengthening procedure performed within 3 months prior to baseline.
- Known clinically significant untreated intestinal obstruction contributing to feeding intolerance and inability to reduce PS.
- Evidence of clinically significant obstruction on upper GI series done within 6 months prior to baseline.
- Previous use of octreotide or Dipeptidyl peptidase-4 (DPP-4) inhibitors within 3 months prior to baseline.
- Signs of active, severe, or unstable clinically significant hepatic impairment during the screening or baseline period, indicative by any of the following laboratory test results:
Show all 17Show fewer
- Total Bilirubin Level (TBL) >= 2 × upper limit of normal (ULN)
- Aspartate Aminotransferase (AST) >=7 × ULN
- Alanine Aminotransferase (ALT) >=7 × ULN
- For Participants with Gilbert's disease:
- Indirect (unconjugated) bilirubin >=2 × ULN
- Signs of known continuous active or unstable, clinically significant renal dysfunction shown by results of an estimated glomerular filtration rate (eGFR) below 50 millilitres per minutes per 1.73 meter square (mL/min/1.73 m^2).
- Known hypersensitivity of the active substance or excipient of teduglutide.
- Body weight less than (<) 10 kg at baseline.
- Previous use of teduglutide or native/synthetic Glucagon-like Peptide-2 (GLP-2).
- Previous use of GLP-1 analog or human growth hormone within 3 months prior to baseline.
- Any condition, disease, illness, or circumstance that in the investigator's opinion puts the patient at any undue risk, prevents completion of the study, or interferes with analysis of the study results.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Not yet recruiting
Guangzhou Women And Children's Medical Center
Guangzhou, Guangdong, 510040
Jiakang Yu
- Not yet recruiting
Children's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310006
Jinfa Tou
- Not yet recruiting
Shanghai Children's Hospital
Shanghai, Shanghai Municipality, 200062
Zhibao Lv
- Recruiting
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Fan Lv
About this study
Official title: A Multicenter, Retrospective and Prospective, Observational Study to Evaluate the Efficacy and Safety of Subcutaneous Teduglutide in the Treatment of Short Bowel Syndrome (SBS) in Parenteral Nutrition (PN) Dependent Chinese Pediatric Subjects (≥1 Through 17 Years Old)
Short Bowel Syndrome (SBS) is a rare condition that happens when a large part of the bowel (also called intestine) is missing or has been removed because of illness or surgery. In children, SBS means that the intestine cannot absorb enough food, water and important part of food the body needs (called nutrients) because a big part of it has been removed, bypassed or did not develop normally at birth and the children need support through a vein (parenteral support or PS) for more than 42 days to stay healthy and keep their energy. SBS in children is defined mainly by how well the intestine works and how long the children need this support, not just by how long the intestine is.
The main aim of the study is to learn how well the teduglutide works in children and teenagers with SBS and who need PS. Another aim is to find out how well teduglutide works for participants to lower the amount of PS needed. Also, the study wants to learn more about how safe teduglutide is in children and teenagers with SBS who need PS.
The study will review data already existing in the medical records of participants as well as collect new data during the study.
- Conditions
- Short Bowel Syndrome (SBS)
- Being tested
- No Intervention
- Keywords
- Drug Therapy
- 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.
No InterventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Group | Participants who completed the 24-week teduglutide treatment period before enrollment will have their clinical data collected retrospectively from their medical records. Receives: Other: No Intervention | |
| Mixed Group | Participants who initiated treatment before the study start date but have not completed the 24-week teduglutide treatment period at the time of enrollment will have their clinical data collected retrospectively before enrollment and prospectively after enrollment. Receives: Other: No Intervention | |
| Prospective Group | Participants who will initiate the teduglutide treatment period after enrollment will have their clinical data collected prospectively for 48 weeks. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieve at Least a 20% Reduction from Baseline in Weekly Parenteral Support (PS) Volume at Week 24
Percentage of participants who achieve at least a 20 percent (%) reduction from baseline in weekly PS volume at Week 24 will be reported.
Measured: At Week 24
Secondary outcomes (34)
Number of Participants Able to Completely Wean off PS Support at Week 24
Number of participants who are able to completely wean off PS support at Week 24 will be reported.
Measured: At Week 24
Absolute Change from Baseline in PN/Intravenous (IV) Support Volume
Absolute change from baseline in PN/IV support volume will be reported.
Measured: Baseline up to Week 24
Percent Change From Baseline in PN/IV Support Volume
Percent change from baseline in PN/IV support volume will be reported.
Measured: Baseline up to Week 24
Absolute Change From Baseline in PN/IV Support Calories
Absolute change from baseline in PN/IV support calories will be reported.
Measured: Baseline up to Week 24
Percent Change From Baseline in PN/IV Support Calories
Percent change from baseline in PN/IV support calories will be reported.
Measured: Baseline up to Week 24
Absolute Change From Baseline in Plasma Citrulline
Absolute change from baseline in plasma citrulline will be reported.
Measured: Baseline, Week 24
Percent Change From Baseline in Plasma Citrulline
Percent change from baseline in plasma citrulline will be reported.
Measured: Baseline, Week 24
Absolute Change From Baseline in Enteral Nutrition (EN) Support Volume
Absolute change from baseline in EN support volume will be reported.
Measured: Baseline up to Week 24
Percent Change From Baseline in EN Support Volume
Percent change from baseline in EN support volume will be reported.
Measured: Baseline up to Week 24
Absolute Change From Baseline in EN Support Calories
Absolute change from baseline in EN support calories will be reported.
Measured: Baseline up to Week 24
Percent Change From Baseline in EN Support Calories
Percent change from baseline in EN support calories will be reported.
Measured: Baseline up to Week 24
Change From Baseline in Hours per day of PN/IV Support
Change from baseline in hours per day of PN/IV support will be reported.
Measured: Baseline up to Week 24
Change From Baseline in Days per Week of PN/IV Support
Change from baseline in days per week of PN/IV support will be reported.
Measured: Baseline up to Week 24
Percentage of Participants with at Least a 20% Reduction From Baseline in PN/IV Volume
Percentage of participants with at least a 20% reduction from baseline in PN/IV volume will be reported.
Measured: Baseline up to Week 24
Change in Body Weight
Change in body weight will be reported.
Measured: Baseline up to Week 24
Change in Height
Change in height will be reported.
Measured: Baseline up to Week 24
Change in Head Circumference
Head circumference will be measured in participants 36 months of age and younger.
Measured: Baseline up to Week 24
Change in Height Z-score
Height is measured using Z-score. Z score is calculated as ([observed value/M]^L-1)/S*L, where observed value is the child's height. The L, M, and S values vary according to the child's sex and age.
Measured: Baseline up to Week 24
Change in Weight Z-score
Weight is measured using Z-score. Z score is calculated as ([observed value/M]^L-1)/S*L, where observed value is the child's weight. The L, M, and S values vary according to the child's sex and age.
Measured: Baseline up to Week 24
Change in Body Mass Index (BMI)
BMI is a simple measure that uses a participant's weight and height to estimate whether they are underweight, normal weight, overweight, or obese. It is calculated as weight in kilograms (kg) divided by height in meters squared (kg/m^2). Change in BMI will be reported.
Measured: Baseline up to Week 24
Change in BMI Z-score
BMI is measured using Z-score. Z score is calculated as ([observed value/M]^L-1)/S*L, where observed value is the child's BMI. The L, M, and S values vary according to the child's sex and age.
Measured: Baseline up to Week 24
Number of Participants with Adverse Events (AEs). Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product. An AE does not necessarily have a causal relationship withthis treatment. An AE can therefore be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product (investigational or marketed), whether or not considered related to treatment with the medicinal product. SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in a congenital abnormality/birth defect, or is an important medical event. An AESI is an AE (serious or nonserious) of scientific and medical concern specific to the product or program.
Measured: Up to 50 weeks
Number of Participants with Clinically Significant Change in Vital Sign Values
Vital signs will include measurement of temperature, heart rate, blood pressure and respiratory rate. Any clinically significant change in vital signs will be determined at the investigator's discretion.
Measured: Up to 24 weeks
Body Weight in Participants Dependent on PS
Body weight in kg will be collected and reported.
Measured: Baseline up to Week 24
Head Circumference in Participants Dependent on PS
Head circumference in participants 36 months of age and younger will be collected and reported.
Measured: Baseline up to Week 24
Height in Participants Dependent on PS
Height in centimeters (cm) will be collected and reported.
Measured: Baseline up to Week 24
Trends on Growth Chart
Trends on growth chart will be collected and reported.
Measured: Baseline up to Week 24
Urine Output Determined up to Week 24
Collected and calculated values of urine output will be recorded over a 48-hour period of PN/IV and EN stability before every clinic visit and within 1 week of implementing a change in the PN/IV prescription.
Measured: Baseline up to Week 24
Fecal Output Measured by Volume
Collected and calculated values of fecal output should be recorded over a 48-hour period of PN/IV and EN stability before every clinic visit and within 1 week of implementing a change in the PN/IV prescription.
Measured: Baseline up to Week 24
Fecal Output Measured by Number of Bowel Movements per Day
Fecal output should be recorded over a 48-hour period of PN/IV and EN stability before every clinic visit and within 1 week of implementing a change in the PN/IV prescription.
Measured: Baseline up to Week 24
Number of Participants with Gastrointestinal-specific Testing
Gastrointestinal-specific testing will include colonoscopy or sigmoidoscopy or upper gastrointestinal (GI) endoscopy, abdominal ultrasound, fecal occult blood testing (FOBT), upper gastrointestinal series small bowel follow-through (UGI SBFT).
Measured: Baseline up to Week 24
Number of Participants With Clinically Significant Changes in Physical Examinations
Physical examination will include assessing the participants physical status. (general surface, skin, head and neck, chest [heart, lungs, breasts], abdomen [gastrointestinal, liver and gallbladder], back, urinary system, limbs, nervous system, lymph nodes, etc.). Any clinically significant change in physical examination will be determined at the investigator's discretion.
Measured: Up to 24 weeks
Number of Participants With Clinically Significant Changes in Laboratory Values
Laboratory parameters will include hematology, chemistry and urinalysis. Any clinically significant change in laboratory values will be determined at the investigator's discretion.
Measured: Up to 24 weeks
Number of Participants With Clinically Significant Changes in 12-Lead Electrocardiogram (ECG) Parameters
The 12-lead ECG will be evaluated. Any clinically significant change in ECG assessment will be determined at the investigator's discretion.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start5 Mar 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Bowel Syndrome (SBS)Studies 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
- Other
- Enrolment
- 12 participants (estimated)
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
- NCT07319832
- Sponsor's protocol ID
- TAK-633-5002
- Status last verified
- Mar 2026
- First submitted
- 22 Dec 2025
- Last updated
- 13 Mar 2026
- 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 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Retrospective and Prospective, Observational Study to Evaluate the Efficacy and Safety of Subcutaneous Teduglutide in the Treatment of Short Bowel Syndrome (SBS) in Parenteral Nutrition (PN) Dependent Chinese Pediatric Subjects (≥1 Through 17 Years Old)
- ClinicalTrials.gov ID
- NCT07319832
- Acronym / sponsor ID
- TAK-633-5002
- Conditions
- Short Bowel Syndrome (SBS)
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 6 Jan 2026 (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.
Short Bowel Syndrome (SBS) is a rare condition that happens when a large part of the bowel (also called intestine) is missing or has been removed because of illness or surgery. In children, SBS means that the intestine cannot absorb enough food, water and important part of food the body needs (called nutrients) because a big part of it has been removed, bypassed or did not develop normally at birth and the children need support through a vein (parenteral support or PS) for more than 42 days to stay healthy and keep their energy. SBS in children is defined mainly by how well the intestine works and how long the children need this support, not just by how long the intestine is.
The main aim of the study is to learn how well the teduglutide works in children and teenagers with SBS and who need PS. Another aim is to find out how well teduglutide works for participants to lower the amount of PS needed. Also, the study wants to learn more about how safe teduglutide is in children and teenagers with SBS who need PS.
The study will review data already existing in the medical records of participants as well as collect new data during the study.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Retrospective Group | – | Other: No InterventionParticipants who completed the 24-week teduglutide treatment period before enrollment will have their clinical data collected retrospectively from their medical records. |
| Mixed Group | – | Other: No InterventionParticipants who initiated treatment before the study start date but have not completed the 24-week teduglutide treatment period at the time of enrollment will have their clinical data collected retrospectively before enrollment and prospectively after enrollment. |
| Prospective Group | – | Other: No InterventionParticipants who will initiate the teduglutide treatment period after enrollment will have their clinical data collected prospectively for 48 weeks. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population consists of Chinese pediatric participants with SBS who are dependent on PS.
Key inclusion criteria (5 listed)
- Children and adolescents greater than or equal to (>=)1 through 17 years of age at Day 1 (D1).
- Documented diagnosis of SBS.
- Received or plan to receive Teduglutide treatment for a minimum of 24 weeks.
- Stable PN/IV support, defined as inability to significantly reduce PN/IV support, usually associated with minimal or no advance in enteral feeds (i.e., 10% or less change in PN or advance in feeds) for at least 3 months prior to D1, as assessed by the investigator. Transient instability for events such as interruption of central access or treatment for sepsis is allowed if the PN/IV support returns to within 10% of baseline prior to the event.
- Informed consent obtained from the patient aged 8 to 17 years and their guardians, while informed consent from the guardians for participants under 8 years old, unless waived by the Institution's Ethics Committee.
Key exclusion criteria (17 listed)
- Participants who are not expected to be able to advance oral or tube feeding regimens.
- Serial Transverse Enteroplasty (STEP) or any other bowel lengthening procedure performed within 3 months prior to baseline.
- Known clinically significant untreated intestinal obstruction contributing to feeding intolerance and inability to reduce PS.
- Evidence of clinically significant obstruction on upper GI series done within 6 months prior to baseline.
- Previous use of octreotide or Dipeptidyl peptidase-4 (DPP-4) inhibitors within 3 months prior to baseline.
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 |
|---|---|---|
| No InterventionNo Intervention | Other | Mixed Group, Prospective Group, Retrospective Group |
Primary outcome
Percentage of Participants Who Achieve at Least a 20% Reduction from Baseline in Weekly Parenteral Support (PS) Volume at Week 24
Time frame: At Week 24
Percentage of participants who achieve at least a 20 percent (%) reduction from baseline in weekly PS volume at Week 24 will be reported.
34 secondary outcomes
Number of Participants Able to Completely Wean off PS Support at Week 24
Time frame: At Week 24
Absolute Change from Baseline in PN/Intravenous (IV) Support Volume
Time frame: Baseline up to Week 24
Percent Change From Baseline in PN/IV Support Volume
Time frame: Baseline up to Week 24
Absolute Change From Baseline in PN/IV Support Calories
Time frame: Baseline up to Week 24
Percent Change From Baseline in PN/IV Support Calories
Time frame: Baseline up to Week 24
Absolute Change From Baseline in Plasma Citrulline
Time frame: Baseline, Week 24
Percent Change From Baseline in Plasma Citrulline
Time frame: Baseline, Week 24
Absolute Change From Baseline in Enteral Nutrition (EN) Support Volume
Time frame: Baseline up to Week 24
Percent Change From Baseline in EN Support Volume
Time frame: Baseline up to Week 24
Absolute Change From Baseline in EN Support Calories
Time frame: Baseline up to Week 24
Percent Change From Baseline in EN Support Calories
Time frame: Baseline up to Week 24
Change From Baseline in Hours per day of PN/IV Support
Time frame: Baseline up to Week 24
Change From Baseline in Days per Week of PN/IV Support
Time frame: Baseline up to Week 24
Percentage of Participants with at Least a 20% Reduction From Baseline in PN/IV Volume
Time frame: Baseline up to Week 24
Change in Body Weight
Time frame: Baseline up to Week 24
Change in Height
Time frame: Baseline up to Week 24
Change in Head Circumference
Time frame: Baseline up to Week 24
Change in Height Z-score
Time frame: Baseline up to Week 24
Change in Weight Z-score
Time frame: Baseline up to Week 24
Change in Body Mass Index (BMI)
Time frame: Baseline up to Week 24
Change in BMI Z-score
Time frame: Baseline up to Week 24
Number of Participants with Adverse Events (AEs). Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Time frame: Up to 50 weeks
Number of Participants with Clinically Significant Change in Vital Sign Values
Time frame: Up to 24 weeks
Body Weight in Participants Dependent on PS
Time frame: Baseline up to Week 24
Head Circumference in Participants Dependent on PS
Time frame: Baseline up to Week 24
Height in Participants Dependent on PS
Time frame: Baseline up to Week 24
Trends on Growth Chart
Time frame: Baseline up to Week 24
Urine Output Determined up to Week 24
Time frame: Baseline up to Week 24
Fecal Output Measured by Volume
Time frame: Baseline up to Week 24
Fecal Output Measured by Number of Bowel Movements per Day
Time frame: Baseline up to Week 24
Number of Participants with Gastrointestinal-specific Testing
Time frame: Baseline up to Week 24
Number of Participants With Clinically Significant Changes in Physical Examinations
Time frame: Up to 24 weeks
Number of Participants With Clinically Significant Changes in Laboratory Values
Time frame: Up to 24 weeks
Number of Participants With Clinically Significant Changes in 12-Lead Electrocardiogram (ECG) Parameters
Time frame: Up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Click here for more information about this trial in easy-to-understand language.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link 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.
Study Director study director
Takeda
4 sites 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 (SBS), run by Takeda at 4 sites in China.
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 17 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: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Achieve at Least a 20% Reduction from Baseline in Weekly Parenteral Support (PS) Volume at Week 24 (time frame: At Week 24). 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 13 Mar 2026.