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 人开始时间: 2021年9月10日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 4month old 至 ot applicable（—）
- 性别
- All
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.
- •11. Known or suspected intolerance or hypersensitivity to the study drug, closely related compounds, or any of the stated ingredients.
- •12. Signs of active, severe, or unstable clinically significant hepatic impairment during the screening period as meeting at least 2 of any of the following parameters:
- •a. International normalized ratio >1.5 not corrected with parenteral vitamin K
- •b. Platelet count <100x10^3/mcrL due to portal hypertension
- •c. Presence of clinically significant gastric or esophageal varices
- •d. Cirrhosis
- •e. Persistent cholestasis defined as conjugated bilirubin >4 mg/dL (>68 mcr mol/L) over a 2-week period during screening
- •f. Total bilirubin >=2x upper limit of normal (ULN)
- •g. Aspartate aminotransferase (AST) >=3x ULN
- •h. Alanine aminotransferase (ALT) >=3x
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