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
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
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
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
