Investigator-initiated Clinical Trial to Evaluate the Efficacy and Safety of Fish Oil-based Intravenous Fat Emulsion for Pediatric Parenteral Nutrition-associated Cholestasis (Intestinal Failure-associated Liver Disease)

Wada Motoshi0 个研究点目标入组 20 人开始时间: 2023年11月7日最近更新: 2023年11月20日

试验速览

阶段: 3 期
状态: 招募中
发起方
入组人数: 20

研究概览入排标准研究者记录与标识符相似试验

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: >= 至 < 15age old（—）
性别: All

入选标准

•1. Male and female children under the age of 15 at the time of obtaining consent.
•2. Patients for whom written consent has been obtained from a legally authorized representative. For patients aged 6 or older, it is preferable to obtain written consent from the patient themselves after explanation via an assent document, in addition to consent from the legally authorized representative. Verbal consent is acceptable if obtaining written consent from the patient is challenging due to physical conditions. In cases where obtaining either written or verbal consent from the patient is difficult, written consent from the legally authorized representative alone is sufficient.
•3. Patients with pediatric intestinal failure (short bowel syndrome, functional intestinal failure, or due to other conditions) who are expected to require parenteral nutrition for more than 6 weeks (42 days), and who meet either or both of the following criteria for intestinal failure-associated liver disease:
•Either AST or ALT levels are more than three times the upper limit of the normal range.
•Presence of parenteral nutrition-associated cholestasis with a d-Bil level greater than 1 mg/dL.

排除标准

•1.Patients diagnosed with or strongly suspected to have comorbidities that may cause liver disease with cholestasis other than intestinal failure and parenteral nutrition, such as viral hepatitis,biliary atresia, primary biliary cholestasis, or lipid metabolism disorders.
•2.Patients who have irreversible advanced liver dysfunction or liver failure, meeting any of the following criteria:
•Severe jaundice (serum t-Bil >= 15 mg/dL)
•Signs of portal hypertension:
•Hypersplenism: a spleen-to-left kidney ratio of 1.35 or greater with accompanying thrombocytopenia (=< 30,000/mm3) or
•leukopenia (=< 500/mm3)
•Gastrointestinal variceal bleeding
•Uncontrollable ascites despite diuretics
•Severe uncorrectable coagulation disorders(PT-INR >= 1.6)
•Hepatic encephalopathy grade III or above with hyperammonemia (>= 100 ug/dL)
•3.Patients with severe chromosomal abnormalities (e.g., Trisomy 13, Trisomy 17), or complicated by respiratory failure, heart failure, or renal failure, where the trial's safety or reliable assessment is deemed challenging by the Principal Investigator or Co-investigator.
•4.Patients scheduled to undergo surgery unrelated to the trial treatment within 56 days after enrollment.
•5.Patients with a known hypersensitivity (allergy) to parenteral lipid emulsions like Omegaven(registered trademark) or its ingredients.
•6.Patients who have not passed 28 days since the completion of participation in another clinical trial or interventional study.
•7.Patients who have received Omegaven(registered trademark) or other agents, supplements, or enteral nutrition products aimed at supplementing or enhancing n-3 fatty acids within 28 days prior to obtaining consent, and who cannot undergo a washout period of at least 28 days (or 14 days for patients under 1 year of age) after consent. However, administration of already approved (soy-derived) lipid emulsions in Japan is not a concern.
•8.Any other patients deemed ineligible by the Principal Investigator or Co-investigator.

研究者

发起方

Wada Motoshi

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