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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024583
Receipt No. R000028295
Scientific Title Clinical use of Omegaven for intestinal failure-associated liver disease(IFALD) and parenteral nutrition associated cholestasis(PNAC)
Date of disclosure of the study information 2016/11/01
Last modified on 2018/10/05

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Basic information
Public title Clinical use of Omegaven for intestinal failure-associated liver disease(IFALD) and parenteral nutrition associated cholestasis(PNAC)
Acronym Clinical use of Omegaven for neonates
Scientific Title Clinical use of Omegaven for intestinal failure-associated liver disease(IFALD) and parenteral nutrition associated cholestasis(PNAC)
Scientific Title:Acronym Clinical use of Omegaven for neonates
Region
Japan

Condition
Condition Intestinal failure-associated liver disease and parenteral nutrition-associated cholestasis
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery
Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assessment the validity of OMEGAVEN for IFALD and PNAC
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of liver dysfunction
Key secondary outcomes

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 intravenous administration of OMEGAVEN (fish oil)
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

Not applicable
Gender Male and Female
Key inclusion criteria The patients admitted to our hospital suffered from IFALD or PNAC with direct bilirubin>2mg/dl
Key exclusion criteria 1. The case with a side effect (hemolysis and hepatic fibrosis ,etc)
2. The case who dose not improve cholestasis for 3 month
3. The rejection for this study from a patient or his family
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Nagaya
Organization Asahikawa Medical University
Division name Department of Pediatrics
Zip code
Address 2-1-1-1,Midorigaoka-higashi, Asahikawa, HOKKAIDO
TEL 0166-68-2481
Email nagaya5p@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken Nagaya
Organization Asahikawa Medical University
Division name Department of Pediatrics
Zip code
Address 2-1-1-1,Midorigaoka-higashi, Asahikawa, HOKKAIDO
TEL 0166-68-2481
Homepage URL
Email nagaya5p@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

Funding Source
Organization Asahikawa Medical University
Organization
Division
Category of Funding Organization Other
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
2016 Year 11 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 Terminated
Date of protocol fixation
2016 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 27 Day
Last modified on
2018 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028295

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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