UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021948
Receipt number R000025301
Scientific Title Randomized control study for the effectiveness of tenofovir in nucleoside/nucleotide analogue-treated patients with chronic HBV infection
Date of disclosure of the study information 2016/05/01
Last modified on 2021/01/26 18:23:30

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Basic information

Public title

Randomized control study for the effectiveness of tenofovir in nucleoside/nucleotide analogue-treated patients with chronic HBV infection

Acronym

Tenofovir study in NA-treated patients with HBV

Scientific Title

Randomized control study for the effectiveness of tenofovir in nucleoside/nucleotide analogue-treated patients with chronic HBV infection

Scientific Title:Acronym

Tenofovir study in NA-treated patients with HBV

Region

Japan


Condition

Condition

chronic HBV infection

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In this randomized control study, the entecavir-treated patients with chronic HBV infection are assigned to two groups: tenofovir-switch group and entecavir-continue group. Then we investigate the virological effects, the emergence rate of drug-resistant mutants, and the biochemical effects. The lamivudine/adefovir-teated patietns are assinged to two groups: lamivudine/tenofovir group and tenofovir alone group. Then we compare the efficacies as above.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The decline of HBsAg 2 years after the enrollment

Key secondary outcomes

The negativity of HBV DNA and HBeAg, and the normalization of ALT


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Switch to tenofovir 300 mg/day in patients treated with entecavir 0.5 mg/day and observe for 2 years

Interventions/Control_2

Continue entecavir 0.5 mg/day in patients treated with entecavir and observe for 2 years

Interventions/Control_3

Switch to lamivudine 100 mg/day and tenofovir 300 mg/day in patients treated with lamivudine and adefovir 10 mg/day and observe for 2 years

Interventions/Control_4

Switch to tenofovir 300 mg/day alone in patients treated with lamivudine 100 mg/day and adefovir 10 mg/day and observe for 2 years

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 chronic HBV infection who have been treated with entecavir or combination of adefovir and lamivudine for more than 1 year
(2) HBV DNA is less than 4.0 log copies/ml
(3) The liver disease is chronic hepatitis or compensated liver cirrhosis (up to Clid-Pugh grade A)

Key exclusion criteria

(1) Patients who is received interferon treatments
(2) Patients who is taking immunosuppressive agents
(3) Patients who have present or past hepatocellular carcinoma, or other malignant diseases
(4) Patients who have decompensated liver cirrhosis
(5) Patients who have renal dysfunction (eGFR is less than 50 ml/min/1.72m2)
(6) Patients who have low serum phosphorus (less than 2.5 mg/dl)
(7) Patients who are pregnant or have possibility of pregnancy
(8) Breast-feeding patients
(9) Patients who is infected also with HIV or HCV
(10) Patients who is participating other studies
(11) Patients who is considered inappropriate for this study by doctors in attendance

Target sample size

180


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Jun Inoue

Organization

Tohoku University Hospital

Division name

Division of Gastroenterology

Zip code


Address

1-1 Seiryo, Aoba-ku, Sendai, Miyagi

TEL

022-717-7171

Email

jinoue-drgn@umin.net


Public contact

Name of contact person

1st name
Middle name
Last name Eiji Kakazu

Organization

Tohoku University Hospital

Division name

Division of Gastroenterology

Zip code


Address

1-1 Seiryo, Aoba-ku, Sendai, Miyagi

TEL

022-717-7171

Homepage URL


Email

eijikakazu@gmail.com


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

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

東北大学病院(宮城県)、大曲厚生医療センター(秋田県)、岩手県立中央病院(岩手県)、気仙沼市立病院(宮城県)、石巻市立病院(宮城県)、東北労災病院(宮城県)、仙台赤十字病院(宮城県)


Other administrative information

Date of disclosure of the study information

2016 Year 05 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

Completed

Date of protocol fixation

2016 Year 05 Month 01 Day

Date of IRB

2016 Year 04 Month 15 Day

Anticipated trial start date

2016 Year 05 Month 01 Day

Last follow-up date

2019 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

2016 Year 04 Month 17 Day

Last modified on

2021 Year 01 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025301


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name