JPRN-jRCT2021210035
已完成
3 期
A Phase 3, Open-label Safety Study of Teduglutide in Japanese Pediatric Patients with Short Bowel Syndrome who are Dependent on Parenteral Support, Aged 4 Months of Corrected Gestational Age or older, and Requiring the Dosing of 1.25 mg Formulation
Koumura Emiko0 个研究点目标入组 3 人2021年9月10日
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Short Bowel Syndrome
- 发起方
- Koumura Emiko
- 入组人数
- 3
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Male or female pediatric patient of corrected gestational age 4 months or older.
- •2\. Body weight at the time of screening and baseline visits of at least 5 kg and \<10 kg for participants with normal renal function or mild renal impairment (estimated glomerular filtration rate \>\=50 mL/min/1\.73 m^2\), OR at least 10 kg and \<20 kg for participants with moderate or greater renal impairment (estimated glomerular filtration rate \<50 mL/min/1\.73 m^2\).
- •3\. Diagnosis of short bowel syndrome (SBS) with intestinal failure, defined as dependence on parenteral support (PS) to provide at least 30% of fluid or caloric needs.
- •4\. Participants to have stable PS for at least 1 month prior to screening as assessed by the investigator. Stable PS is defined as inability to significantly reduce parenteral nutrition/intravenous fluid (PN/IV) support, usually associated with minimal or no advance in enteral feeds (ie, 10% or less change in PN or advance in feeds), assessed by the investigator.
排除标准
- •1\. A parent/guardian who is not capable of understanding or not willing to adhere to the study visit schedule and other protocol requirements.
- •2\. Clinically significant intestinal obstruction, active or recurrent pancreatic or biliary disease, or dysmotility that prevents the advancement of enteral intake.
- •3\. Intestinal malabsorption due to a genetic condition, such as cystic fibrosis, microvillus inclusion disease, etc.
- •4\. 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 PS, prior to screening. Dysmotility is defined as severe if it is expected to limit the advancement of enteral feeding.
- •5\. Major gastrointestinal (GI) surgical intervention including significant intestinal resection or bowel lengthening procedure within 3 months prior to screening (insertion of feeding tube, anastomotic ulcer repair, minor intestinal resections \=\<10 cm and endoscopic procedures are allowed).
- •6\. Cardiac disease that makes the patient vulnerable to changes in fluid status.
- •7\. History of cancer or 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).
- •8\. Concurrent treatment with glucagon\-like peptide\-2 (GLP\-2\), human growth hormone, or analogs of these hormones within 6 months prior to the screening visit, or concurrent treatment with octreotide, or GLP\-1 analogs within 30 days prior to the screening visit.
- •9\. Concurrent treatment with biological therapy (eg, anti\-tumor necrosis factor \[anti\-TNF]) for active Crohn's disease within 6 months prior to the screening visit.
- •10\. Participation in a clinical study using an experimental drug (other than glutamine or omegaven) within 3 months or 5\.5 half\-lives of the experimental drug, whichever is longer, prior to the screening visit and for the duration of the study.
结局指标
主要结局
未指定
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