UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001914 |
|---|---|
| Receipt number | 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 11:45:24 |
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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
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
wada@ped-surg.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002328
