UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025725 |
|---|---|
| Receipt number | R000029388 |
| Scientific Title | Evaluation of safety and protective efficacy of fulminant hepatitis to abatacept treatment of patients with HBV-related severe hepatitis.-Pilot Study- |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2023/01/22 11:22:45 |
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Basic information
Public title
Evaluation of safety and protective efficacy of fulminant hepatitis to abatacept treatment of patients with HBV-related severe hepatitis.-Pilot Study-
Acronym
A pilot study of abatacept treatment for HBV fulminant hepatitis prevention.
Scientific Title
Evaluation of safety and protective efficacy of fulminant hepatitis to abatacept treatment of patients with HBV-related severe hepatitis.-Pilot Study-
Scientific Title:Acronym
A pilot study of abatacept treatment for HBV fulminant hepatitis prevention.
Region
| Japan |
Condition
Condition
HBV-related acute severe hepatitis
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 predicted HBV-related fulminant hepatitis.
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 severe hepatitis improved one week after treatment (Ratio of patient that PT was restored than 70%)
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 predicted HBV-related fulminant hepatitis.
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
Hospitalized patients who satisfied all of the following selection criteria for patients with hepatitis B(acute infection, acute exacerbation, reactivation), understand the purpose of this study, and consent by written document.
1) HBs antig en positive
2) ALT 100 IU / ml or more
3) Male and female with ag es 18 to 85 at the time of acquiring consent
Key exclusion criteria
1) PT less than 10%
2) PT 61% or more, and either AST or ALT is on a downward trend
3) Hepatic encephalopathy 2 deg rees or more
4) Patients with autoimmune hepatitis
5) Patients with a history of hypersensitivity to orencia
6) Patients with severe infection
7) In addition, patients judg ed unsuitable for participation in this study by research doctor.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Michio |
| Middle name | |
| Last name | Imamura |
Organization
graduate school of biomedical science, Hiroshima university.
Division name
Department and medicine and molecular science
Zip code
734-8551
Address
1-2-3 kasumi, minami-ku, Hiroshima 734-8551
TEL
082-257-5190
mimamura@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Nakahara |
Organization
graduate school of biomedical science, Hiroshima university.
Division name
Department and medicine and molecular science
Zip code
734-8551
Address
1-2-3 kasumi, minami-ku, Hiroshima 734-8551
TEL
082-257-5190
Homepage URL
nakahara@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima university hospital
Institute
Department
Personal name
Funding Source
Organization
Hiroshima 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
Hiroshima University Certified Review Board
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Hiroshima
Tel
08 2 -2 5 7 -1 5 5 1
iryo-seisaku@office.hiroshima-u.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
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 18 | Day |
Last modified on
| 2023 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029388
