[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"short-bowel-syndrome-sbs\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:short-bowel-syndrome-sbs":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,75,101,124],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100649960","phase-3-a-study-to-investigate-the-efficacy-and-safety-of-apraglutide-compared-with-placebo-in-adult-participants-with-short-bowel-syndrome-associated-with-intestinal-failure-sbs-if-100649960",false,"NCT07742735","A Study to Investigate the Efficacy and Safety of Apraglutide Compared With Placebo in Adult Participants With Short Bowel Syndrome Associated With Intestinal Failure (SBS-IF)","A Parallel-group Treatment, Phase 3, Double-blind, Randomized, 2-arm Study to Investigate the Efficacy and Safety of Apraglutide Compared With Placebo in Adult Participants With Short Bowel Syndrome Associated With Intestinal Failure (SBS-IF)","STARS-2","Inclusion Criteria:\n\n* Participant must be ≥18 years of age, at the time of signing the informed consent.\n* Male and female participants with SBS-IF, receiving PS secondary to surgical resection of the small intestine with residual length ≥10 cm to \\\u003C200 cm from duodeno-jejunal flexure, based on available clinical and\u002For medical\u002Fsurgical records, and with either: (a.) CIC remaining and neither jejunostomy nor ileostomy with the latest intestinal resection resulting in SBS-IF being at least 12 months prior to Screening OR (b.) Jejunostomy or ileostomy with the latest intestinal resection resulting in SBS-IF being at least 6 months prior to Screening.\n* BMI of ≥18.5 to \\\u003C30 kg\u002Fm2 at randomization.\n* Individuals of any gender identity, assigned male or female at birth are eligible to participate. Male participants: Male participants with a female partner of childbearing potential must commit to practice highly effective methods of contraception (eg, condom, vasectomy) and abstain from sperm donation during the study and for 2 weeks after the EOT\u002FEarly Discontinuation (ED) Visit. Female participants: Women of childbearing potential must agree to practice effective contraception and to use a highly effective method of contraception during the study and for 4 weeks after the EOT\u002FED Visit. To be considered sterilized or infertile, female participants must have undergone surgical sterilization (hysterectomy, bilateral salpingectomy and bilateral oophorectomy) or be postmenopausal (defined as at least 12 months amenorrhea without an alternative medical cause; a follicle-stimulating hormone \\[FSH\\] test \\[with or without estradiol\\] is required to confirm if there is doubt). Women who do not engage in heterosexual intercourse will be allowed to join the study without contraception following a thorough discussion with the investigator to determine if this is feasible for the participant. The following are not considered acceptable methods of contraception: calendar, ovulation, symptothermal, postovulation methods, withdrawal (coitus interruptus), spermicides only, and the lactational amenorrhea method.\n* Signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.\n* PS requirement of at least 3 days per week as assessed before Screening, at the end of optimization, and at the time of randomization.\n* Participant is considered optimized (average drinking volume is ≥1.0 L and ≤3.5 L per day and the average urinary volume is ≥0.8 L and ≤2.5 L per day) at study Visit 2a, 2b, or 2c.\n* Participant is considered stable with regard to PS volume requirement, drinking volume, and urinary output at last Stabilization Phase Visit and Visit 4 when the actual PS usage matches prescribed PS (±10% deviation in volume from the last optimization visit), average urine volume at the last stabilization visit and randomization visit match (±25% deviation from last optimization visit is acceptable), while the average drinking volume is constant (the 48-hour oral intake differs from the last optimization visit by less than 10% and minimum 1.0 and maximum 3.5 L per day) and average urine volume is ≥0.8 L and ≤2.5 L per day.\n* Willingness to adhere to an individual predefined drinking menu and urine measurements during the 48-hour fluid balance periods.\n* No planned restorative surgery or major intestinal surgery (more than 10% intestinal resection or surgery that changes anatomy group, ie, CIC or stoma) from the signing of informed consent through completion of the SFU visit.\n* Willingness to undergo either a colonoscopy or CT\u002FMRI colonography (if anatomically feasible and medically appropriate) and have any identified polyps removed.\n\nExclusion Criteria:\n\n* Pregnancy and\u002For lactation and\u002For plans to become pregnant or to breastfeed.\n* Major abdominal surgery (more than 10% intestinal resection or surgery that changes anatomy group) in the last 6 months prior to Screening Visit. Surgery for feeding tube placement and cholecystectomy allowed, after discussion with medical monitor and appropriate documentation. Any planned surgical procedures during the study duration must be discussed with the medical monitor prior to enrollment, with appropriate documentation of approval of eligibility, if applicable.\n* Ultra-short gut (residual length \\\u003C10 cm from duodeno-jejunal flexure).\n* A history of clinically significant intestinal adhesions increasing the risk of GI obstruction and\u002For GI contrast study(ies) of remaining small bowel suggesting subacute intestinal obstruction or mild stricture within 6 months prior to Screening.\n* Constipation that is not adequately managed by dietary recommendations, laxatives, or cathartic medications.\n* Active or untreated enterocutaneous fistula.\n* History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within ≤5 years, except for adequately treated basal cell skin cancer.\n* Diagnosis of any variant of familial adenomatous polyposis or comparable polyposis syndrome.\n* Active inflammatory bowel disease or any other acute or chronic related underlying medical condition that, in the opinion of the investigator, would limit the participant's ability to complete or participate in the study, or confound study results. Discussion with the medical monitor is required.\n* Sepsis experienced within the previous 2 months prior to or during Screening; or a central venous catheter infection requiring the use of systemic antibiotics within 30 days prior to or during Screening, with the exception of systemic antibiotics administered for \\\u003C72 hours while awaiting the results of pending blood culture(s) that turn out negative (ie, \\\u003C72 hours empiric systemic antibiotics while ruling out a central venous catheter infection is allowed as long as the culture turns out negative).\n* Decompensated heart failure (New York Heart Association class III-IV) and\u002For known coronary heart disease defined as unstable angina pectoris and\u002For myocardial infarction within the previous 6 months prior to Screening.\n* Radiation enteritis, scleroderma, or residual evidence of intestinal dysmotility, including pseudo-obstruction and Hirschsprung's disease, coeliac disease, refractory or tropical sprue.\n* History of alcohol or drug abuse within the previous 12 months prior to Screening that, in the opinion of the investigator, could interfere with study participation, compliance, and safety of participants.\n* Child-Pugh scale Class C for liver disease.\n* Evidence of chronic renal disease as demonstrated by inadequate renal function, which is defined as estimated glomerular filtration rate \\\u003C20 mL\u002Fmin\u002F1.73 m2 (using the Chronic Kidney Disease Epidemiology formula).\n* Positive results for HIV, hepatitis A, B, and\u002For C tests at the Screening Visit. Note: Participants recovered from hepatitis B or C can be enrolled, ie, they have markers of the infection, but the viral load is undetectable. Participants with evidence of an acute or chronically active hepatitis B or C infection should be excluded. If a participant has a positive hepatitis A immunoglobulin M test, this would indicate an acute infection and the participant is ineligible, but they may be eligible for rescreening after recovery. Participants with positive HIV test results and undetectable viral loads may be rescreened (in case the initial test was a false positive).\n* Clinically significant concurrent illness (eg, uncontrolled hypertension, pancreatic or gallbladder disease) or finding on physical examination or clinical laboratory test after signing the ICF but before receiving the first dose of IMP. Note: The investigator will determine if a finding is clinically significant. The investigator will consider whether the finding 1) could prevent the participant from performing any study procedure or assessment, 2) represents a condition that would be exclusionary, 3) could represent a safety concern if the participant participated in the study, or 4) could confound any study assessment.\n* Elevated liver enzymes during the screening period: (a.) ALT or AST \\>5 × upper limit of normal (ULN); (b.) ALT or AST \\>3 × ULN and total bilirubin (TBL) \\>2 × ULN or international normalized ratio (INR) \\>1.5 for a person not using anticoagulant drug and INR \\>3 for a person on anticoagulant therapy such as warfarin; (c.) ALT or AST \\>3 × ULN and clinical signs of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and\u002For eosinophilia; (d.) Participants with serum conjugated bilirubin \\>34 μmol\u002FL during 2 consecutive measurements.\n* Use of diuretics, anti-diarrheals, and other common concomitant medications used in SBS-IF if dosing is not stable within 14 days prior to randomization.\n* New drug treatment other than biologic therapies, or a change to the dose or dosing interval of an existing drug treatment other than a biologic, within 1 month prior to randomization. In cases of weight loss or weight gain, dose adjustments that enable the same drug unit\u002Fkg dosing (eg, mg\u002Fkg) for weight-based dosing are permitted within 1 month prior to randomization after discussion with the medical monitor and proper documentation.\n* New biologic therapy or changes to dose or dosing interval of existing biologic therapy within 3 months prior to Screening, unless the dose adjustment was due to a change in weight and maintained the same drug-unit\u002Fkg (eg, mg\u002Fkg) weight-based dosing. Switching from a reference biologic product to a biosimilar, while maintaining the same dose and dosing interval, is permitted outside the 3 months prior to the screening window and\u002For during the study.\n* Use of dipeptidyl peptidase-4 inhibitors within 3 months prior to Screening.\n* At least 2 weeks of treatment with growth factors, such as growth hormone, glutamine, native GLP-2, GLP-1, short acting GLP-2 analogs (eg, teduglutide) or GLP-1 analogs within 3 months before Screening; or treatment with longer acting experimental GLP-2 analogs in the previous 6 months before Screening. Note: Prior discontinuation of GLP-2 analog treatment due to safety concerns or lack of efficacy is an exclusion criterion regardless of wash-out period. For prior discontinuation due to intolerance, the patient may be eligible based on discussion with the medical monitor. The nature of the intolerance must be clearly documented and discussed with the medical monitor.\n* Citrulline supplements within less than 30 days prior to Screening.\n* Prior use of apraglutide, or prior randomization in this study. Note: Randomization to placebo in a prior study of apraglutide is not an exclusion criterion.\n* Known or suspected hypersensitivity to GLP-1 or GLP-2 analogs or any apraglutide excipients.\n* Known antidrug antibodies (ADAs) against GLP-1 or GLP-2 analogs.\n* Participation in another interventional clinical study in the last 3 months before screening and during this study (studies with catheter locks or observational studies, which are not a burden on the participant and do not interfere with the participation in this study, are allowed after discussion with the medical monitor).\n* Incapable of understanding or unwilling to adhere to the study visit schedules and\u002For other protocol requirements.\n* Inability to prepare and\u002For administer the dose of the study intervention or inability to have the dose prepared and\u002For administered by an appropriately trained care provider.\n* Any condition, underlying disease, or circumstance, including psychosocial or environmental that, in the opinion of the investigator, could reduce the participant's adherence with the study visit schedule, dosing regimen, or other study requirements.\n* Participant is directly or indirectly involved in the conduct and administration of this study as an investigator, subinvestigator, study coordinator, study staff member, or employee of the sponsor; or the participant is a direct relative of an individual involved in the study.","ALL","18 Years",{"count":20,"type":21},124,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This Phase 3 placebo-controlled study is planned to further investigate the efficacy, safety, and tolerability of apraglutide in the overall SBS-IF (short bowel syndrome associated with intestinal failure) population during 24 weeks of study treatment. It is expected that approximately 124 participants will be randomized worldwide to either apraglutide or placebo in a 1:1 ratio in this trial.",[27,28],"Short Bowel Syndrome (SBS)","SBS Associated With Intestinal Failure (SBS-IF)",[30,31,32,33],"Short Bowel Syndrome","Intestinal Failure","SBS","SBS-IF","RECRUITING","2026-08-03",{"date":37,"type":38},"2026-08-04","ACTUAL",{"date":40,"type":21},"2026-08",{"date":42,"type":21},"2029-10",{"name":44,"class":45},"VectivBio AG","INDUSTRY",94,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100633697","role-of-the-microbiota-in-intestinal-adaptation-during-short-bowel-syndrome-100633697","NCT07530055","Role of the Microbiota in Intestinal Adaptation During Short Bowel Syndrome","Role of the Microbiota in Intestinal Adaptation During Short Bowel Syndrome: a Longitudinal Follow-up","AdMIR","Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosis of short bowel syndrome with a jejunostomy and a plan to restore jejuno-colic continuity within 3 months\n* Remaining post-duodenal small intestine (after the ligament of Treitz) \\\u003C 200 cm\n* Remaining colon \\> 14%\n* Remaining small intestine and colon are healthy (no residual inflammatory, post-radiation, or ischemic disease)\n* Patient enrolled in a social security system or entitled to coverage\n\nExclusion Criteria:\n\n* Pregnancy\n* Patient unable to provide consent:\n* Due to a disability preventing consent\n* Does not understand French\n* Patient deprived of liberty, or under legal protection (guardianship or curatorship)\n* Participation in another interventional study",{"count":56,"type":21},15,[58],"NA","During the first years following intestinal resection, spontaneous physiological adaptations occur in patients with short bowel syndrome (SBS), allowing improvement of the absorptive capacity of the remaining intestine. This adaptation is particularly effective in SBS patients with the colon in continuity. The specific relationship between this intestinal adaptation and changes in the gut microbiota has not been studied in these patients. We hypothesize that there is a specific relationship between the microbiota and its metabolites and intestinal adaptive capacity, and that certain gut bacteria may promote this spontaneous adaptation.",[27],[30,62,63],"Intestinal Adaptation","Gastrointestinal Microbiome","NOT_YET_RECRUITING","2026-04-08",{"date":67,"type":38},"2026-04-15",{"date":69,"type":21},"2026-04",{"date":71,"type":21},"2029-02",{"name":73,"class":74},"Assistance Publique - Hôpitaux de Paris","OTHER",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"100617531","a-study-of-teduglutide-in-chinese-children-and-teenagers-with-short-bowel-syndrome-100617531","NCT07319832","A Study of Teduglutide in Chinese Children and Teenagers With Short Bowel Syndrome","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)","Inclusion criteria\n\n* Children and adolescents greater than or equal to (\\>=)1 through 17 years of age at Day 1 (D1).\n* Documented diagnosis of SBS.\n* Received or plan to receive Teduglutide treatment for a minimum of 24 weeks.\n* Stable PN\u002FIV support, defined as inability to significantly reduce PN\u002FIV 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\u002FIV support returns to within 10% of baseline prior to the event.\n* 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.\n\nExclusion criteria\n\n* Participants who are not expected to be able to advance oral or tube feeding regimens.\n* Serial Transverse Enteroplasty (STEP) or any other bowel lengthening procedure performed within 3 months prior to baseline.\n* Known clinically significant untreated intestinal obstruction contributing to feeding intolerance and inability to reduce PS.\n* Evidence of clinically significant obstruction on upper GI series done within 6 months prior to baseline.\n* Previous use of octreotide or Dipeptidyl peptidase-4 (DPP-4) inhibitors within 3 months prior to baseline.\n* 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:\n\n  1. Total Bilirubin Level (TBL) \\>= 2 × upper limit of normal (ULN)\n  2. Aspartate Aminotransferase (AST) \\>=7 × ULN\n  3. Alanine Aminotransferase (ALT) \\>=7 × ULN\n\n     For Participants with Gilbert's disease:\n  4. Indirect (unconjugated) bilirubin \\>=2 × ULN\n* 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\u002Fmin\u002F1.73 m\\^2).\n* Known hypersensitivity of the active substance or excipient of teduglutide.\n* Body weight less than (\\\u003C) 10 kg at baseline.\n* Previous use of teduglutide or native\u002Fsynthetic Glucagon-like Peptide-2 (GLP-2).\n* Previous use of GLP-1 analog or human growth hormone within 3 months prior to baseline.\n* 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.","1 Year","17 Years",{"count":85,"type":21},12,"OBSERVATIONAL","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.\n\nThe 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.\n\nThe study will review data already existing in the medical records of participants as well as collect new data during the study.",[27],[90],"Drug Therapy","2026-03-11",{"date":93,"type":38},"2026-03-13",{"date":95,"type":38},"2026-03-05",{"date":97,"type":21},"2027-09-30",{"name":99,"class":45},"Takeda",4,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":83,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":123},"100623757","tedorg-study-on-short-bowel-syndrome-100623757","NCT07400783","TED_ORG: Study on Short Bowel Syndrome","Short Bowel Syndrome: Human Intestinal Organoids to Investigate the Different Efficacy of the GLP-2 Analogue Teduglutide in Pediatric Patients With Short Bowel Syndrome","Inclusion Criteria:\n\n* Patients or His\u002Fher Parents\u002F legal guardian must provide informed consent before they can participate in the study.\n* Paediatric patients: Male and female patients aged ≥ 4 months old and ≤ 18 years;\n* SBS patient or patient undergoing intestinal resective surgery\n\nExclusion Criteria:\n\n* Adult patients (≥ 18 years old);\n* Patients who have never undergone intestinal resective surgery\n* Current or past use of teduglutide","4 Months",{"count":110,"type":21},50,[58],"The goal of this clinical trial is to understand why pediatric patients with short bowel syndrome respond differently to treatment with the glucagon-like peptide-2 (GLP-2) analogue teduglutide. Short bowel syndrome is a rare and severe condition in children that results from extensive intestinal resection and leads to impaired nutrient absorption, chronic diarrhea, and dependence on parenteral nutrition. Although teduglutide is known to promote intestinal adaptation and improve absorption, the clinical response varies widely among patients, and the biological mechanisms underlying this variability are not fully understood.\n\nThis study aims to investigate the effects of teduglutide using human intestinal organoids derived from intestinal tissue samples of pediatric patients with short bowel syndrome. Intestinal organoids are three-dimensional structures grown from patient-derived stem cells that reproduce key structural and functional characteristics of the human intestine. These organoids provide a human-based experimental model that allows the study of intestinal morphology, cellular behavior, and nutrient absorption in a controlled in vitro environment.\n\nThe main questions this study aims to answer are:\n\nDoes treatment with teduglutide improve the absorptive capacity of human intestinal organoids derived from pediatric patients with short bowel syndrome?\n\nAre there differences in intestinal structure, cellular proliferation, and gene expression between teduglutide-treated organoids and untreated organoids?\n\nAre specific molecular or cellular features associated with different responses to teduglutide?\n\nResearchers will compare intestinal organoids treated with teduglutide to untreated organoids obtained from the same patients. This comparison will be used to evaluate changes in organoid morphology, expression of receptors involved in intestinal growth and absorption, activity of nutrient transporters, and overall absorptive function. The study will also explore differences between organoids derived from patients who show different clinical responses to teduglutide.\n\nParticipants in this study are pediatric patients with short bowel syndrome or patients undergoing intestinal resection surgery as part of their standard clinical care. No experimental treatment is administered directly to participants as part of this study. Intestinal tissue samples are collected only during clinically indicated surgical procedures and are not obtained specifically for research purposes.\n\nParticipants will:\n\nProvide intestinal tissue samples collected during routine or clinically indicated intestinal surgery\n\nHave intestinal organoids generated from their tissue samples using established laboratory techniques\n\nHave their organoids studied in vitro with and without exposure to teduglutide to evaluate intestinal structure, gene and protein expression, and nutrient absorption mechanisms\n\nThe results of this study are expected to improve understanding of the biological mechanisms underlying variable responses to teduglutide and may contribute to the development of more personalized treatment strategies for pediatric patients with short bowel syndrome in the future.",[27],"2026-02-06",{"date":116,"type":38},"2026-02-10",{"date":118,"type":38},"2024-10-30",{"date":120,"type":21},"2026-10",{"name":122,"class":74},"Meyer Children's Hospital IRCCS",1,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":123},"100482408","a-survey-to-assess-participants-and-physicians-knowledge-when-using-gattex-knowledge-assessment-survey-100482408","NCT05561647","A Survey to Assess Participants' and Physicians' Knowledge When Using GATTEX (Knowledge Assessment Survey)","Quantitative Testing of Patient and Prescriber Knowledge About GATTEX (Teduglutide) for Injection Safety and Use Information","Participant inclusion criteria:\n\nParticipants who are 18 years of age and who have taken GATTEX in the 60 days prior to survey implementation are eligible to participate in the survey. A caregiver may participate in this survey on behalf of a participant who is eligible but unable to complete the survey. Note: Participants who have previously participated in a GATTEX Patient Knowledge Assessment Survey, are eligible.\n\nPrescriber inclusion criteria:\n\nHCPs (adult and pediatric) in the United States who can provide a 10-digit National Provider Identifier (NPI) number and who have prescribed GATTEX at least once regardless of their completion of the voluntary GATTEX REMS training (Prescriber Education Slide Deck) are eligible for participation in the survey. Note: HCPs who have previously participated in a GATTEX Prescriber Knowledge Assessment Survey, are eligible\n\nParticipant and Prescriber exclusion criteria:\n\n* Respondents who do not agree to participate in the survey.\n* Respondents who are currently working for and\u002For whose immediate family members who are currently working for Takeda Pharmaceuticals U.S.A., Inc., NPS Pharmaceuticals, Inc., Shire, UBC, or the Food and Drug Administration (FDA) are not eligible to participate in the survey.\n* Respondents who reported having a conflict of interest.\n* HCPs who have opted out of receiving communications about the GATTEX Prescriber Knowledge Assessment Survey for the current wave\n\nFurther details associated with respondents who do not meet the exclusion criteria established above, will be provided in the assessment report.",{"count":132,"type":21},600,"The study is about learning and documenting how well participants and physicians understand how to use GATTEX and about potential risks by using a survey (called Knowledge Assessment Survey). This survey, which is conducted every two years, is part of the Gattex Risk Evaluation and Mitigation Strategy (REMS). REMS is a safety program required by the US health authority (FDA) for certain medicines that have serious risks. REMS intends to help reduce these risks while still allowing treatment. The goal is to make sure these medicines are used in the safest way possible. The main aim of this survey is to find out how well participants and physicians understand the checkups and tests (so called monitoring) participants should have while taking GATTEX, and the possible risks or of using GATTEX to treat Short Bowel Syndrome.\n\nThe knowledge assessment survey will be done via internet, telephone, or paper and both physicians and participants will be able to choose the method that is preferred.\n\nNo study medicines will be provided to participants in this study.",[27],"2026-01-23",{"date":137,"type":38},"2026-01-26",{"date":139,"type":38},"2013-08-01",{"date":141,"type":21},"2031-12-31",{"name":99,"class":45}]