Omegaven investigator-initiated trial

Phase 3

Recruiting

• Conditions: ICD-10: K76.8, ICD-11: DB99.60; Parenteral nutrition associated cholestasisIntestinal failure associated liver disease; Intestinal failure associated liver disease

• Registration Number: JPRN-jRCT2021230032
• Lead Sponsor: Wada Motoshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-07
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
T/T Ratio (Triene/Tetraene Ratio) at Day 56 following the initiation of investigational drug administration.