UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035046 |
|---|---|
| Receipt number | R000039955 |
| Scientific Title | Efficacy and safety of TAF prophylactic administration for HBV reactivation hepatitis during immunosuppressive or anti-tumor therap |
| Date of disclosure of the study information | 2018/11/28 |
| Last modified on | 2018/11/28 11:05:42 |
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Basic information
Public title
Efficacy and safety of TAF prophylactic administration for HBV reactivation hepatitis during immunosuppressive or anti-tumor therap
Acronym
TAF for prevention of HBV
reactivation
Scientific Title
Efficacy and safety of TAF prophylactic administration for HBV reactivation hepatitis during immunosuppressive or anti-tumor therap
Scientific Title:Acronym
TAF for prevention of HBV
reactivation
Region
| Japan |
Condition
Condition
Patients with current or previous HBV infection
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy and safety of TAF prophylactic administration for patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of prevention to HBV reactivation hepatitis at 1 year after initiation of TAF
Key secondary outcomes
1) The rate of prevention to HBV reactivation hepatitis at 2 years after initiation of TAF
2) Disappear of serum HBV-DNA, at 1 years after treatment initiation
3) Safety of TAF administration
4) The change of serum HBs antigen titer during the therapy
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Inclusion criteria 1) Patients aged 20 years or older at the time of consent 2) Patients who received an adequate explanation prior to the study and provided written consent for participation in the study 3) (i) Patients who are HBs Ag positive and/or HBV-DNA positive and receive TAF administration for preventing HBV reactivation, ahead of anti-tumor therapy (for solid tumor, malignant lymphoma or leukemia ) or immunosuppressive therapy (for auto immune disease (RA, SLE, nephrosis syndrome, et al),. (ii) Patients who does not meet the criteria described above (i) with previous HBV infection who experience HBV reactivation during anti-tumor therapy or immunosuppressive therapy and receive TAF administration for preventing HBV reactivation hepatitis.
Key exclusion criteria
1) Patients with a past history of hypersensitivity to TAF 2) Patients with serious liver dysfunction (Child-Pugh Class B or C) 3) Patients with difficult-to-control heart disease (e.g., myocardial infarction, heart failure, and arrhythmia) 4) Liver transplantation 5) Patients who are not expected to be survived more than 12 month by the primary physician. 6) Other patients judged to be inappropriate to participate in the study by the primary physician
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Goki Suda |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
North 15, West 7, Kita-ku, Sapporo, Hokkaido
TEL
011-716-2111
gsudgast@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Goki Suda |
Organization
Graduate School of Medicine, Hokkaido University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
North 15, West 7, Kita-ku, Sapporo, Hokkaido
TEL
011-716-2111
Homepage URL
gsudgast@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido university
Institute
Department
Personal name
Funding Source
Organization
Gilead Sciences, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 11 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 06 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | 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
Viral factors
Peripheral blood tests
Liver function
Biochemistry
Fibrosis markers
Glucose Blood coagulation PT INR
Measurement of liver stiffness
CT or US
Management information
Registered date
| 2018 | Year | 11 | Month | 28 | Day |
Last modified on
| 2018 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039955
