EUCTR2016-000849-30-FI进行中（未招募）1 期
A Prospective, Open-label, Long-term Safety and Efficacy Study ofTeduglutide in Pediatric Patients with Short Bowel Syndrome WhoCompleted TED-C14-006 or SHP633-301Original PIP P/238/2010
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Study Inclusion Criteria:
- •The subject will be considered eligible for the study if they meet all of the study inclusion criteria. Teduglutide treatment eligibility does not impact study eligibility.
- •1. Subject provides written informed consent (subject, parent or legal guardian and, as appropriate, informed assent) to participate in the study before completing any study-related procedures.
- •2. Subject completed the TED-C14-006 or SHP633-301 studies (including subjects in the standard of care treatment arms). Subjects are considered to have completed SHP633-301 if they completed study assessments through week 24.
- •3. Subject understands and is willing and able to fully adhere to study requirements
- •Teduglutide Eligibility Criteria:
- •Subjects are eligible for teduglutide treatment if at least one (=1) of the teduglutide treatment inclusion criteria, and none of the teduglutide treatment exclusion criteria, are met. In addition, the investigator and the subject (and/or parent or legal guardian, as appropriate) must agree to proceed with treatment.
- •Teduglutide Treatment Inclusion Criteria:
- •1. Subject is teduglutide-naïve, receiving parenteral support (PS), and unable to significantly reduce PS or advance enteral feeds (e.g., 10% or less change in PS or advance in feeds) for at least 3 months prior to and during the teduglutide pretreatment visit, as assessed by the investigator. Transient instability for events such as interruption of central access or treatment for sepsis is allowed if the PS returns to within 10% of baseline prior to the event.
- •2. Subject was previously treated with teduglutide and at least one of the following criteria is satisfied:
- •a. Increasing PS requirements following teduglutide discontinuation.
- •b. Decreased PS requirement during prior teduglutide treatment, followed by cessation of improvement after teduglutide discontinuation.
- •c. Deteriorating nutritional status (e.g., weight loss or growth failure) despite maximal tolerated enteral nutrition (EN) following teduglutide discontinuation.
- •d. Deteriorating fluid or electrolyte status despite maximal tolerated enteral fluid and electrolyte intake following teduglutide discontinuation.
- •e. Severe diarrhoea related to teduglutide discontinuation.
- •Follow-up Period Escape Criteria:
- •At the discretion of the investigator, the follow-up period may be interrupted or omitted and the subject may proceed directly to the pretreatment visit, if 1 of the following criteria is met:
- •1. Increasing PS requirements following teduglutide discontinuation
- •2. Deteriorating nutritional status (e.g., weight loss or growth failure) despite maximal tolerated EN following teduglutide discontinuation.
- •3. Deteriorating fluid or electrolyte status despite maximal tolerated enteral fluid and electrolyte intake following teduglutide discontinuation.
- •4. Severe diarrhoea related to teduglutide discontinuation.
- •5. The subject escaped during the follow-up period of SHP633-301 or during the follow-up period of a previous teduglutide treatment cycle within SHP633-304.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Study Exclusion Criteria:
- •There are no exclusion criteria for this study.
- •Teduglutide Treatment Exclusion Criteria:
- •1. Body weight <5 kg at the pre-treatment visit.
- •2. Unresected gastrointestinal (GI) polyp, known polyposis condition, premalignant change, or malignancy, in the GI tract.
- •3. History of cancer in the previous 5 years except surgically curative skin cancers.
- •4. Serial transverse enteroplasty or other major intestinal surgery within 3 months preceding the teduglutide pretreatment visit. Insertion of a feeding tube, anastomotic ulcer repair, minor intestinal resections =10 cm, and endoscopic procedures are allowed.
- •5. Intestinal or other major surgery planned or scheduled to occur during the 28-week cycle.
- •6. Clinically significant intestinal stricture or obstruction.
- •7. Clinically significant, active or recurrent pancreatic or biliary disease.
- •8. Active, severe, or unstable, clinically significant hepatic impairment or injury, including the following laboratory values at the pretreatment visit:
- •a. Total bilirubin =2 × upper limit of normal (ULN)
- •b. Aspartate aminotransferase (AST) =7 × ULN
- •c. Alanine aminotransferase (ALT) =7 × ULN
- •9. Renal dysfunction shown by results of an estimated glomerular filtration rate below 50 mL/min/1.73 m2 at the pretreatment visit.
- •10. Unstable cardiac disease, congenital heart disease or cyanotic disease, with the exception of subjects who had undergone ventricular or atrial septal defect repair, or patent ductus arteriosus ligation.
- •11. Participation in a clinical study using an experimental drug (other than glutamine, Omegaven or Smoflipid) within 3 months or 5.5 half-lives of the experimental drug, whichever is longer, prior to the pretreatment visit and for the duration of the 28-week cycle.
- •12. Treatment with analogs of glucagon-like peptide-1 (GLP-1), glucagon-like peptide-2 (GLP-2) (not including teduglutide), insulin-like growth factor-1 (IGF-1), or growth hormone, within 3 months preceding the teduglutide pretreatment visit.
- •13. Treatment with octreotide or dipeptidyl peptidase 4 (DPP-4) inhibitors within 3 months prior to the pretreatment visit.
- •14. Known or suspected intolerance or hypersensitivity to the investigational product, closely-related compounds, or any of the stated ingredients.
- •15. Known history of alcohol or other substance abuse within 1 year prior to the pretreatment visit.
- •16. Pregnant or lactating female subjects.
- •17. Sexually active female subjects of child-bearing potential unwilling to use approved contraception during teduglutide treatment and for 30 days after the treatment period.
- •18. Any condition, disease, illness, or circumstance that in the investigator’s opinion puts the subject at any undue risk, prevents completion of the study, or interferes with analysis of the study results.
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