UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034362 |
|---|---|
| Receipt number | 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 | 2021/06/23 06:30:15 |
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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 | Tomomi |
| Middle name | |
| Last name | Okubo |
Organization
Nippon Medical Chiba Hokusoh Hospital
Division name
Department of gastroenterology
Zip code
2701613
Address
1715, Kamagari, Inzai, Chiba
TEL
0476-99-1111
mid@mtc.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | Norio |
| Middle name | |
| Last name | Itokawa |
Organization
Nippon Medical Chiba Hokusoh Hospital
Division name
Department of gastroenterology
Zip code
2701613
Address
1715, Kamagari, Inzai, Chiba
TEL
0476-99-1111
Homepage URL
mid@mtc.biglobe.ne.jp
Sponsor or person
Institute
Nippon Medical Chiba Hokusoh Hospital
Institute
Department
Personal name
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
Nipon medical Chiba hokuso Hospital
Address
1715 Kamagari Inzai Chiba
Tel
0476991111
araraki@nms.ac.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
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
| 2021 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039169
