UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial treatment of intestinal failure and parenteral nutrition associated liver disease using an omega-3 fatty acid (fish oil) based intravenous fat emulsion, OMEGAVEN
Title of the study (Brief title)	Treatment of intestinal failure using OMEGAVEN
Region	Japan

Condition
Condition	intestinal failure and parenteral nutrition associated liver disease
Classification by specialty	Hepato-biliary-pancreatic medicine Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the safety and efficacy of Omegaven, an omega-3 fatty acid based intravenous fat emulsion made from a fish oil in the treatment the treatment of intestinal failure and parenteral nutrition induced liver disease.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	resolution of parenteral nutrition associated liver disease ( PNALD) as measured by normalization of serum levels of hepatic enzymes and bilirubin. optimization of nutrition status
Key secondary outcomes	progression to liver/intestinal transplant, death from liver failure

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	treat with OMEGAVEN
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	19 years-old >
Gender	Male and Female
Key inclusion criteria	Patients must be enrolled in the Intestinal Rehabilitation Program at the Tohoku University Hospital, AND: Be unable to meet nutritional needs solely by enteral nutrition and be expected to require PN for at least another 30 days Have clinical evidence of parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of 2 mg/dl or more/clinical sign of portal hypertension, Signed patient informed consent
Key exclusion criteria	Patient (parent or guardian of child) unwilling to provide consent or assent Inability or unwillingness on the part of parent/guardian or child to follow clinical recommendations of the Intestinal Rehabilitation Program Allergies or clinical conditions precluding safe use of Omegaven
Target sample size	10

Research contact person
Name of lead principal investigator	Nio Masaki
Organization	Tohoku University School of Medicine
Division name	Department of Pediatric Surgery
Address	1-1 Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7237
Email	mnio@ped-surg.med.tohoku.ac.jp

Public contact
Name of contact person	Wada Motoshi
Organization	Tohoku University School of Medicine
Division name	Department of Pediatric Surgery
Address	1-1 Seiryo-machi, Aobaku, Sendai
TEL	022-717-7237
Homepage URL
Email	wada@ped-surg.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Hospital
Institute
Department

Funding Source
Organization	Tohoku University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2009 Year 05 Month 01 Day

Progress
Recruitment status
Date of protocol fixation	2009 Year 04 Month 15 Day
Anticipated trial start date	2009 Year 04 Month 01 Day
Last follow-up date	2014 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2009 Year 04 Month 27 Day
Last modified on	2017 Year 12 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002328