UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016148 |
|---|---|
| Receipt number | R000018749 |
| Scientific Title | Evaluation of safety and efficacy to abatacept treatment of patients with HBV-related acute liver failure.-Pilot Study- |
| Date of disclosure of the study information | 2015/01/07 |
| Last modified on | 2017/01/10 21:42:04 |
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Basic information
Public title
Evaluation of safety and efficacy to abatacept treatment of patients with HBV-related acute liver failure.-Pilot Study-
Acronym
A pilot study of abatacept treatment in actu HBV patients with liver failure.
Scientific Title
Evaluation of safety and efficacy to abatacept treatment of patients with HBV-related acute liver failure.-Pilot Study-
Scientific Title:Acronym
A pilot study of abatacept treatment in actu HBV patients with liver failure.
Region
| Japan |
Condition
Condition
HBV-related acute liver failure
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy to abatacept treatment of patients with HBV-related acute liver failure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Ratio of patient with liver failur improved one week after treatment (Ratio of patient that PT was restored than 50%)
Key secondary outcomes
Period of ALT being normalized
Safety (moniterd clinical and laboratory evaluation)
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
To evaluate safety and efficacy to abatacept treatment of patients with HBV-related acute liver failure.
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
HBs antigen positive
Less than PT 40%
Key exclusion criteria
1) Autoimmune hepatitis
2) History of hypersensitivity to abatacept
3) Hepatic coma
4) HBV carrier
5) Serious infectious disease
6) Judged by investigator not to be appropriate for inclusion in this study
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuaki Chayama |
Organization
graduate school of biomedical science, Hiroshima university.
Division name
Department and medicine and molecular science
Zip code
Address
1-2-3 kasumi, minami-ku, Hiroshima 734-8551
TEL
082-257-5190
chayama@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiiku Kawakami |
Organization
graduate school of biomedical science, Hiroshima university
Division name
Department and medicine and molecular science
Zip code
Address
1-2-3 kasumi, minami-ku, Hiroshima 734-8551
TEL
082-257-5190
Homepage URL
kamy4419@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima liver study group
Institute
Department
Personal name
Funding Source
Organization
graduate school of biomedical science, Hiroshima university
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
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 07 | 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
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | 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 | 01 | Month | 07 | Day |
Last modified on
| 2017 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018749
