UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020159
Receipt number 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 12:41:05

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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 or person

Institute

Keio University School of Medicine, Department of Pediatric Surgery

Institute

Department

Personal name



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

Value
https://center6.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