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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025725
Receipt No. 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 2018/02/07

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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 HBs antigen positive
Under PT 60%
Key exclusion criteria 1) Autoimmune hepatitis
2) History of hypersensitivity to abatacept
3) Hepatic coma grade2
4) Above PT 60% or Less than PT10%
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
Email chayama@mba.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nakahara Takashi
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
Email nakahara@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima university hospital
Institute
Department

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
Address
Tel
Email

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 Enrolling by invitation
Date of protocol fixation
2016 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 01 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
2017 Year 01 Month 18 Day
Last modified on
2018 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029388

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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