A Study in Japanese Children With Short Bowel Syndrome Who Completed SHP633-302
Phase 1
- Conditions
- Treatment of short bowel syndromeTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2021-005404-36-Outside-EU/EEA
- Lead Sponsor
- Shire
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- Not specified
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 [IRB]) by the participant prior to any study-related procedures.
- Participant completed Study SHP633-302 (NCT02980666).
- Participant (and/or parent/guardian) understands and is willing and able to fully adhere to study requirements as defined in this protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range: 9
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
There are no exclusion criteria for this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to evaluate the long-term safety and tolerability of teduglutide treatment in Japanese pediatric subjects with SBS who completed Study SHP633-302.;Secondary Objective: The secondary objective of this study is to evaluate the long-term efficacy of teduglutide treatment in Japanese pediatric subjects with SBS who completed Study SHP633-302.;Primary end point(s): - Adverse events<br>- Vital signs, including temperature, heart rate, blood pressure<br>- Laboratory safety data (ie, biochemistry, hematology, and urinalysis)<br>- Urine output<br>- Stool output<br>- Antibodies to teduglutide<br>- Gastrointestinal-specific testing, including fecal occult blood testing and colonoscopy or sigmoidoscopy<br>- Z-scores for weight, height (or length), head circumference (up to 36 months of age), and BMI;Timepoint(s) of evaluation of this end point: Baseline to each study visit for approximately 3 years
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Reduction in parenteral support (PS) volume of at least 20%<br>- Absolute and relative change in PS volume<br>- Complete weaning off PS<br>- Change in days per week of PS;Timepoint(s) of evaluation of this end point: Baseline to each study visit for approximately 3 years