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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001756
Receipt No. R000002080
Scientific Title Hepatitis B immunoglobulin plus Lamivudine to prevent recurrent hepatitis B following liver transplantation
Date of disclosure of the study information 2009/03/05
Last modified on 2013/04/02

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Basic information
Public title Hepatitis B immunoglobulin plus Lamivudine to prevent recurrent hepatitis B following liver transplantation
Acronym HBIG plus LAM to prevent HBV recurrence
Scientific Title Hepatitis B immunoglobulin plus Lamivudine to prevent recurrent hepatitis B following liver transplantation
Scientific Title:Acronym HBIG plus LAM to prevent HBV recurrence
Region
Japan

Condition
Condition Liver transplant candidates with end-stage liver diseases due to hepatitis B.
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and efficacy of HBIG plus LAM therapy among Japanese liver transplant recipients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The rate of hepatitis B recurrence post liver-transplantation.
Key secondary outcomes To compare the rate of Hepatitis B recurrence post liver-transplantation to our histolical control (HBIG alone).

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
Medicine
Interventions/Control_1 Lamivudine
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients undergoing/underwent liver transplantation for hepatitis B-related end-stage liver diseases.
2)Patients who comply with periodical intra-vascular administration of HBIG.
3)HBV-DNA undetectable at 3 weeks post liver transplantation.
4)HBsAg negative at 3 weeks post liver transplantation.
5)GOT <= 2X UNL (upper normal limit) and GPT <= 2X UNL.
Key exclusion criteria 1) HIV co-infection.
2) Lamivudine sensitivity.
3) Severe renal dysfunction (serum Cr >= 2.0 mg/dL)
4) Resistance to Lamivudine.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiko Sugawara
Organization University of Tokyo
Division name The Artificial Organ and Transplantation Division, Department of Surgery
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655
TEL 03-3815-5411
Email

Public contact
Name of contact person
1st name
Middle name
Last name Noriyo Yamashiki
Organization University of Tokyo
Division name Organ Transplantation Service
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655
TEL 03-3815-5411
Homepage URL
Email nyamashiki-gi@umin.ac.jp

Sponsor
Institute Artificial Organ and Transplantation Division, Department of Surgery, Graduate School of Medicine, University of Tokyo
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2009 Year 03 Month 05 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
Target sample size was not achieved.
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
2009 Year 01 Month 22 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2013 Year 03 Month 31 Day
Date of closure to data entry
2013 Year 03 Month 31 Day
Date trial data considered complete
2013 Year 03 Month 31 Day
Date analysis concluded
2013 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2009 Year 03 Month 04 Day
Last modified on
2013 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002080

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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