UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019351 |
|---|---|
| Receipt number | R000022380 |
| Scientific Title | Efficacy and Safety of Granulocytapheresis against severe alcoholic hepatitis |
| Date of disclosure of the study information | 2015/10/14 |
| Last modified on | 2023/01/28 17:38:37 |
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Basic information
Public title
Efficacy and Safety of Granulocytapheresis against severe alcoholic hepatitis
Acronym
Granulocytapheresis against severe alcoholic hepatitis
Scientific Title
Efficacy and Safety of Granulocytapheresis against severe alcoholic hepatitis
Scientific Title:Acronym
Granulocytapheresis against severe alcoholic hepatitis
Region
| Japan |
Condition
Condition
severe alcoholic hepatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate the efficacy and safety of granulocytapheresis against severe alcoholic hepatitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Outcome at 180 days after the initiation of granulocytapheresis
Key secondary outcomes
Changes in clinical parameters including prognostic scores before and after granulocytapheresis
Overall survival during observation
culmative rate of discharge from Liver Unit after granulocytapheresis
Culmative rate of alcoho relapse after granulocytapheresis
Safty
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
| Device,equipment |
Interventions/Control_1
granulocytapheresis
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
the patients who meet the diagnostic criteria of severe alcoholic hepatitis
the patients who are able to keep vascular access
the patients who obtained their written informed consent
Key exclusion criteria
the patients whose granulocyte count are below 2000
the patients who complicated with severe infection, severe heart disease, uncontrolled cancer, and end-stage liver cirrhosis
the patients who are pregnant
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Nakamoto |
Organization
School of Medicine, Keio University
Division name
Division of Gastroenterology & Hepatology, Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku Tokyo
TEL
03-3353-1211
nobuhiro@z2.keio.jp
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Nakamoto |
Organization
School of Medicine, Keio University
Division name
Division of Gastroenterology & Hepatology, Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku Tokyo
TEL
03-3353-1211-62384
Homepage URL
nobuhiro@z2.keio.jp
Sponsor or person
Institute
Division of Gastroenterology & Hepatology, Department of Internal Medicine, School of Medicine, Keio University
Institute
Department
Personal name
Funding Source
Organization
Division of Gastroenterology & Hepatology, Department of Internal Medicine, School of Medicine, Keio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
JIMRO Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University, School of Medicine
Address
35 Shinanomachi Shinjuku-ku, Tokyo
Tel
+81-3-3353-1211
med-rinri-jimu@adst.keio.ac.jp
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 | 10 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 19 | 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 | 10 | Month | 14 | Day |
Last modified on
| 2023 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022380
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
