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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034362
Receipt No. R000039169
Scientific Title Safety and efficacy of Tenofovir alafenamide (TAF) in patients with chronic hepatitis B and cirrhosis.
Date of disclosure of the study information 2018/10/05
Last modified on 2019/04/30

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Basic information
Public title Safety and efficacy of Tenofovir alafenamide (TAF) in patients with chronic hepatitis B and cirrhosis.
Acronym Safety and efficacy of Tenofovir alafenamide (TAF)
Scientific Title Safety and efficacy of Tenofovir alafenamide (TAF) in patients with chronic hepatitis B and cirrhosis.
Scientific Title:Acronym Safety and efficacy of Tenofovir alafenamide (TAF)
Region
Japan

Condition
Condition Chronic hepatitis B and cirrhosis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Safety and efficacy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rates of negativity of hepatitis B surface antigen.
The amount of reduction of hepatitis B surface antigen.
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 Treatment
Type of intervention
Medicine
Interventions/Control_1 vemlidy 25mg/day
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
18 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Chronic hepatitis B
Key exclusion criteria 1.Patients who has allergy to this drugs.
2.Patients with severe kidney disease.
3.Patients who are taking Tenofovir.
4.Patients who are pregnant or breast-feeding.
5.Patients who are judged ineligible by atending physician.

Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norio Itokawa
Organization Nippon Medical Chiba Hokusoh Hospital
Division name Department of gastroenterology
Zip code
Address 1715, Kamagari, Inzai, Chiba
TEL 0476-99-1111
Email mid@mtc.biglobe.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norio Itokawa
Organization Nippon Medical Chiba Hokusoh Hospital
Division name Department of gastroenterology
Zip code
Address 1715, Kamagari, Inzai, Chiba
TEL 0476-99-1111
Homepage URL
Email mid@mtc.biglobe.ne.jp

Sponsor
Institute Nippon Medical Chiba Hokusoh Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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 10 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
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 09 Month 30 Day
Date of IRB
2019 Year 03 Month 14 Day
Anticipated trial start date
2018 Year 10 Month 05 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 02 Day
Last modified on
2019 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039169

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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