UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035046
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email gsudgast@pop.med.hokudai.ac.jp

Sponsor
Institute Hokkaido university
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039955

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.