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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020159
Receipt No. R000023265
Scientific Title The efficacy of Omega-3 fatty acids (Omegaven) for patients with liver disease secondary to intestinal failure
Date of disclosure of the study information 2015/12/10
Last modified on 2015/12/18

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Basic information
Public title The efficacy of Omega-3 fatty acids (Omegaven) for patients with liver disease secondary to intestinal failure
Acronym The efficacy of Omega-3 fatty acids (Omegaven) for patients with liver disease secondary to intestinal failure
Scientific Title The efficacy of Omega-3 fatty acids (Omegaven) for patients with liver disease secondary to intestinal failure
Scientific Title:Acronym The efficacy of Omega-3 fatty acids (Omegaven) for patients with liver disease secondary to intestinal failure
Region
Japan

Condition
Condition intestinal failure associated liver disease
Classification by specialty
Gastrointestinal surgery Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and the efficacy of Omega-3 fatty acids (Omegaven) for patients with liver disease secondary to intestinal failure
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The reduction of direct bilirubin
Key secondary outcomes Histological analysis of the liver, Acoustic Radiation Force Impulse of the liver, nutritional status

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
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
The dose of Omegaven will be initiated from 0.2g/kg/day, and increased step by step up tp 1.0g/kg/day. The Omegaven will be administered via central venous catheter for 12 hours. The duration of the treatment will be from 4 weeks to 24 weeks, based on the blood test.
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 Patients suffering from liver disease associated with intestinal failure and serum Direct Bilirubin > 2.
Key exclusion criteria Conditions including severe infections, poorly controlled diabetes, shock, coagulopathy, fat metabolism disorder, allergic to fish or eggs
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Hoshino
Organization Keio University School of Medicine
Division name Department of Pediatric Surgery
Zip code
Address 35 Shinanomachi Shinjuku-ku Tokyo
TEL 03-5363-3024
Email hoshino@z7.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yohei Yamada
Organization Keio University School of Medicine
Division name Department of Pediatric Surgery
Zip code
Address 35 Shinanomachi Shinjuku-ku Tokyo
TEL 03-5363-3024
Homepage URL
Email yohei@z7.keio.jp

Sponsor
Institute Keio University School of Medicine, Department of Pediatric Surgery
Institute
Department

Funding Source
Organization Keio University School of Medicine, Department of Pediatric Surgery
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
2015 Year 12 Month 10 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 Preinitiation
Date of protocol fixation
2015 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 10 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
2015 Year 12 Month 10 Day
Last modified on
2015 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=R000023265

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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