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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000259 |
Receipt No. | R000000323 |
Scientific Title | Prophylaxis against de novo hepatitis B or hepatitis B recurrence by vaccination for living-donor liver transplant recipients with hepatitis B-related disease: a pilot study |
Date of disclosure of the study information | 2005/10/17 |
Last modified on | 2008/04/08 |
Basic information | ||
Public title | Prophylaxis against de novo hepatitis B or hepatitis B recurrence by vaccination for living-donor liver transplant recipients with hepatitis B-related disease: a pilot study | |
Acronym | HBV vaccination for LDLT recipients | |
Scientific Title | Prophylaxis against de novo hepatitis B or hepatitis B recurrence by vaccination for living-donor liver transplant recipients with hepatitis B-related disease: a pilot study | |
Scientific Title:Acronym | HBV vaccination for LDLT recipients | |
Region |
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Condition | |||
Condition | Hepatitis B, Living-donor liver transplantation recipient | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the effectiveness of hepatitis B vaccination after living-donor liver transplantation |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Acquisition rate of active immunity following hepatitis B vaccination |
Key secondary outcomes | Dose reduction of anti-HBs immunoglobulin infusion after active immunization |
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 | Prevention | |
Type of intervention |
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Interventions/Control_1 | Hepatitis B vaccine | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Living-donor liver transplantation recipient for hepatitis B related diseases.
Living-donor liver transplantation recipient who received a graft from hepatitis B core antibody positive donor. Patients on prophylactic HBIG monotherapy. Negative for hepatitis B surface antigen, hepatitis e antigen, and hepatitis B virus DNA. |
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Key exclusion criteria | Positive for hepatitis C virus or human immunodeficiency virus.
Patients on prophylactic lamivudine therapy. |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | University of Tokyo Hospital | ||||||
Division name | The Artificial Organ and Transplantation Division, Department of Surgery | ||||||
Zip code | |||||||
Address | Hongo 7-3-1, Bunkyo-ku, | ||||||
TEL | |||||||
Public contact | |||||||
Name of contact person |
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Organization | University of Tokyo Hospital | ||||||
Division name | The Artificial Organ and Transplantation Division, Department of Surgery | ||||||
Zip code | |||||||
Address | Hongo 7-3-1, Bunkyo-ku, | ||||||
TEL | 03-3815-5411 | ||||||
Homepage URL | |||||||
Sponsor | |
Institute | The Artificial Organ and Transplantation Division, Department of Surgery |
Institute | |
Department |
Funding Source | |
Organization | The Artificial Organ and Transplantation Division, Department of Surgery |
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 | |
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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 |
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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 | |
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Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000323 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |