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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name