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Study in Japanese Pediatric Subjects With Short Bowel Syndrome (SBS) Who Are Dependent on Parenteral Support | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study in Japanese Pediatric Subjects With Short Bowel Syndrome (SBS) Who Are Dependent on Parenteral Support

A 24-week Safety, Efficacy, Pharmacodynamic, and Pharmacokinetic Study of Teduglutide in Japanese Pediatric Subjects, Aged 4 Months Through 15 Years, With Short Bowel Syndrome Who Are Dependent on Parenteral Support

NCT02980666•Shire

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine if an investigational treatment (teduglutide) is safe and effective in Japanese children (age 4 months through 15 years of age) with SBS who are dependent on parenteral support. This study will also evaluate how teduglutide moves through the body (pharmacokinetics) and how it affects the body (pharmacodynamics).

Eligibility

Age

0 - 15 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Informed consent by a parent or guardian prior to any study-related procedures
•When applicable, informed assent (as deemed appropriate by the Institutional Review Board) by the participant prior to any study-related procedures
•Male or female infant 4 to \<12 months corrected gestational age or child or adolescent aged 1 year through 15 years
•Current history of SBS as a result of major intestinal resection (eg, due to necrotizing enterocolitis, midgut volvulus, intestinal atresia, or gastroschisis)
•Short bowel syndrome that requires PN/IV support that provides at least 30% of caloric and/or fluid/electrolyte needs
•Stable PN/IV support, defined as:
•For infants 4 to \<12 months corrected gestational age: Inability to significantly reduce PN/IV support, usually associated with minimal or no advance in enteral feeds (ie, 10% or less change in PN or advance in feeds) for at least 1 month prior to and during screening, as assessed by the investigator.
•For children 1 to 15 years of age:
•Inability to significantly reduce PN/IV support, usually associated with minimal or no advance in enteral feeds (ie, 10% or less change in PN or advance in feeds) for at least 3 months prior to and during screening, as assessed by the investigator.
•Transient instability for events such as interruption of central access or treatment of sepsis is allowed if the PN/IV support returns to within 10% of baseline prior to the event.
+1 more criteria

Exclusion Criteria

•Participants who are not expected to be able to advance oral or tube feeding regimens
•Serial transverse enteroplasty or any other bowel lengthening procedure performed within 3 months of screening
•Known clinically significant untreated intestinal obstruction contributing to feeding intolerance and inability to reduce parenteral support
•Unstable absorption due to cystic fibrosis or other known DNA abnormalities (eg, Familial Adenomatous Polyposis, Fanconi-Bickel syndrome)
•Severe, known dysmotility syndrome such as pseudo-obstruction or persistent, severe, active gastroschisis-related dysmotility; that is the primary contributing factor to feeding intolerance and inability to reduce parenteral support, prior to screening. Dysmotility is defined as severe if it is expected to limit the advancement of enteral feeding.
•Evidence of clinically significant obstruction on the most recent upper GI series done within 6 months prior to screening.
•Major GI surgical intervention including significant intestinal resection within 3 months prior to screening (insertion of feeding tube, anastomotic ulcer repair, minor intestinal resections \<=10 centimeter (cm), or endoscopic procedure is allowed)
•Unstable cardiac disease or congenital heart disease or cyanotic disease, with the exception of participants who had undergone ventricular or atrial septal defect repair, and patent ductus arteriosus (PDA) ligation
•History of cancer or clinically significant lymphoproliferative disease, not including resected cutaneous basal or squamous cell carcinoma, or in situ nonaggressive and surgically resected cancer. Participants with known cancer predisposition syndrome, such as juvenile polyposis or Beckwith-Wiedemann syndrome, or first degree relative with early onset of GI cancer (including hepatobiliary and pancreatic cancer) will also be excluded.
•Pregnant or lactating female participants
+24 more criteria

Locations (5)

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Tsukuba University Hospital

Tsukuba, Ibaraki, Japan

Kagoshima University

Kagoshima, Kagoshima-ken, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Showa University

Shinagawa-ku, Tokyo-To, Japan

Key Dates

Start Date

January 13, 2017

Primary Completion Date

January 21, 2020

Completion Date

January 21, 2020

Last Updated

February 2, 2022

Enrollment

ACTUAL participants

Conditions

Short Bowel Syndrome

Interventions

Teduglutide

DRUG

Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

NCT07197944

Short Bowel Syndrome

View study

RECRUITING

A Survey to Assess Participants' and Physicians' Knowledge When Using GATTEX (Knowledge Assessment Survey)

NCT05561647

Short Bowel Syndrome (SBS)

View study

RECRUITINGPHASE3

A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome

NCT06973304

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study in Japanese Pediatric Subjects With Short Bowel Syndrome (SBS) Who Are Dependent on Parenteral Support

Inclusion Criteria

Exclusion Criteria

Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

A Survey to Assess Participants' and Physicians' Knowledge When Using GATTEX (Knowledge Assessment Survey)

A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome

A 90 Day Observational Study as an Extension to the Phase 3,Open Labeled Exploratory Study of RELiZORB

Registry for Participants With Short Bowel Syndrome

Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition