UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011543
Receipt number R000013499
Scientific Title A prospective, multiple center trial for incidence and prevention of hepatitis B virus (HBV) reactivation following hematopoietic stem cell transplantation (HSCT)
Date of disclosure of the study information 2013/08/23
Last modified on 2022/07/08 13:37:53

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Basic information

Public title

A prospective, multiple center trial for incidence and prevention of hepatitis B virus (HBV) reactivation following hematopoietic stem cell transplantation (HSCT)

Acronym

A trial for HBV reactivation in HSCT recipients.

Scientific Title

A prospective, multiple center trial for incidence and prevention of hepatitis B virus (HBV) reactivation following hematopoietic stem cell transplantation (HSCT)

Scientific Title:Acronym

A trial for HBV reactivation in HSCT recipients.

Region

Japan


Condition

Condition

Patients with resolved HBV infection who receive hematopoietic stem cell transplantation

Classification by specialty

Hepato-biliary-pancreatic medicine Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To determine preventive effect of HB vaccination against reactivation in HSCT recipients with resolved HBV infection (HBsAg(-), HBcAb(+)), we conducted prospective study.
Frequency of HBV reactivation after HSCT and efficacy of HBV-DNA monitoring will be assessed.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Frequency of HBV reactivation in HSCT recipients immunized with HB vaccination.

Key secondary outcomes



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

Vaccine

Interventions/Control_1

HB vaccination

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Patients who will undergo first HSCT
2. Patients with HBs antigen negative and HBc antibody positive
3. Patients with serum total bilirubin <=2.0mg/dl
4. Patients with serum AST and ALT <= 2.5 x ULN
5. Patients with serum creatinine <= 1.5 xULN
6. Patients with PaO2 >=60Torr on room air or SpO2 >=90%
7.Patients with performance status 0,1 or 2
8. Patients who are 20 to 75 years old
9. Patients who gave consent for this trial

Key exclusion criteria

1. Patients with HCV antibody positive
2. Patients with HIV antibody positive
3. Patients who are allergic to vaccination
4. Patients who are allergic to biologics
5. Patients with severe infectious disease (Patients whose general condition seemed to be poor like as septic shock )
6. Patient who undergo hemodialysis
7. Patients with mental disorder which is object of treatment
8. Patients with poorly controlled DM, HT, or heart failure
9. Patients who are pregnant or nursing
10. Patients who are judged ineligible for this trial

Target sample size

66


Research contact person

Name of lead principal investigator

1st name Kiminori
Middle name
Last name Kimura

Organization

Tokyo Metropolitan Komagome Hospital

Division name

Division of Hepatology

Zip code

113-8677

Address

3-18-22, Honkomagome, Bunkyo-ku, Tokyo

TEL

03-3823-2101

Email

kiminori_kimura@tmhp.jp


Public contact

Name of contact person

1st name Kiminori
Middle name
Last name Kimura

Organization

Tokyo Metropolitan Komagome Hospital

Division name

Division of Hepatology

Zip code

113-8677

Address

3-18-22, Honkomagome, Bunkyo-ku, Tokyo

TEL

03-3823-2101

Homepage URL


Email

kiminori_kimura@tmhp.jp


Sponsor or person

Institute

Kiminori Kimura

Institute

Department

Personal name



Funding Source

Organization

Health labor science research grant

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Komagome Hospital Institutional Review Board

Address

3-18-22, Honkomagome, Bunkyo-ku, Tokyo, Japan

Tel

0338232101

Email

km_koma_chiken@tmhp.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

・東京都立駒込病院(東京都)
・東京都立多摩総合医療センター(東京都)
・自治医科大学附属さいたま医療センター(埼玉県)
・東京医科歯科大学(東京都)
・北海道大学医学部(北海道)
・東北大学病院(宮城県)
・国家公務員共済組合連合会 浜の町病院(福岡県)
・兵庫県立がんセンター(兵庫県)
・東海大学医学部(神奈川県)
・久留米大学医学部(福岡県)
・自治医科大学附属病院(栃木県)


Other administrative information

Date of disclosure of the study information

2013 Year 08 Month 23 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

Completed

Date of protocol fixation

2013 Year 08 Month 16 Day

Date of IRB

2013 Year 08 Month 16 Day

Anticipated trial start date

2013 Year 09 Month 01 Day

Last follow-up date

2019 Year 01 Month 15 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 08 Month 21 Day

Last modified on

2022 Year 07 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013499


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name