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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001914
Receipt No. R000002328
Scientific Title 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
Date of disclosure of the study information 2009/05/01
Last modified on 2017/12/18

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Basic information
Public title 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
Acronym Treatment of intestinal failure using OMEGAVEN
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Nio Masaki
Organization Tohoku University School of Medicine
Division name Department of Pediatric Surgery
Zip code
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
1st name
Middle name
Last name Wada Motoshi
Organization Tohoku University School of Medicine
Division name Department of Pediatric Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status
Date of protocol fixation
2009 Year 04 Month 15 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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