UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017728
Receipt number R000020532
Scientific Title Efficacy and safety of tenofovir disoproxil fumarete (TDF) in nucleos(t)ide analogue-naive patients with hepatitis B virus
Date of disclosure of the study information 2015/06/01
Last modified on 2019/08/02 15:47:33

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Basic information

Public title

Efficacy and safety of tenofovir disoproxil fumarete (TDF) in nucleos(t)ide analogue-naive patients with hepatitis B virus

Acronym

Efficacy and safety of tenofovir disoproxil fumarete (TDF)

Scientific Title

Efficacy and safety of tenofovir disoproxil fumarete (TDF) in nucleos(t)ide analogue-naive patients with hepatitis B virus

Scientific Title:Acronym

Efficacy and safety of tenofovir disoproxil fumarete (TDF)

Region

Japan


Condition

Condition

Patients with chronic hepatitis B virus infection

Classification by specialty

Medicine in general Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assesse the efficacy and safety of tenofovir disoproxil fumarate in nucleos(t)ide analogue-naive patients infected with hepatitis B virus

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

probability of HBV DNA negativity
dicrease rate of HB surface antigen level
dicrease rate of HB core-related antigen
probability of HBe antigen seroconversion
probability of ALT normalization
cumulative incidence rate of hepatocellular carcinoma

Key secondary outcomes



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

1) Patients with 20 years of age and older
2) HB surface antigen positive for over 6 months

Key exclusion criteria

1) pregnant woman
2) co-infection with other hepatitis virus (HCV/HDV/HIV)
3) contraindication to tenofovir disoploxil fumarate

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Tetsuo
Middle name
Last name Takehara

Organization

Osaka University Graduate School of Medicine

Division name

Gastroenterology and Hepatology

Zip code

565-0871

Address

2-2, Yamadaoka, Suita, Osaka, Japan

TEL

81-6-6879-3621

Email

takehara@gh.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name Ryoko
Middle name
Last name Yamada

Organization

Osaka University Graduate School of Medicine

Division name

Gastroenterology and Hepatology

Zip code

565-0871

Address

2-2, Yamadaoka, Suita, Osaka, Japan

TEL

81-6-6879-3621

Homepage URL


Email

ryo726@gh.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University Graduate School of Medicine, Department of Gastroenterology and Hepatology

Institute

Department

Personal name



Funding Source

Organization

Grant-in-Aid for Research on Hepatitis from Ministry of Health Labour and Welfare of Japan, and Scientific Research from the Ministry of Education, Science, and Culture of Japan

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Osaka University Clinical Research Review Committee

Address

2-2, Yamadaoka, Suita, Osaka

Tel

06-6210-8289

Email

rinri@hp-crc.med.osaka-u.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

2015 Year 06 Month 01 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

Enrolling by invitation

Date of protocol fixation

2014 Year 07 Month 10 Day

Date of IRB


Anticipated trial start date

2015 Year 04 Month 18 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To assess the efficacy and safety of tenofovir disoproxil fumarate in patients infected with hepatits B virus.
To investigate the relative factor with antiviral effect, emergence of drug-resistant virus and the suppressive effect for incidence of hepatocellular carcinoma.


Management information

Registered date

2015 Year 05 Month 28 Day

Last modified on

2019 Year 08 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020532


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name