UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of safety and efficacy to abatacept treatment of patients with HBV-related acute liver failure.-Pilot Study-
Title of the study (Brief title)	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	Kazuaki Chayama
Organization	graduate school of biomedical science, Hiroshima university.
Division name	Department and medicine and molecular science
Address	1-2-3 kasumi, minami-ku, Hiroshima 734-8551
TEL	082-257-5190
Email	chayama@hiroshima-u.ac.jp

Public contact
Name of contact person	Yoshiiku Kawakami
Organization	graduate school of biomedical science, Hiroshima university
Division name	Department and medicine and molecular science
Address	1-2-3 kasumi, minami-ku, Hiroshima 734-8551
TEL	082-257-5190
Homepage URL
Email	kamy4419@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima liver study group
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018749