UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003982
Receipt number R000004798
Scientific Title Randomized control trial of increased dose therapy with Entecavir vursus combination therapy with Entecavir and Adefovir in CHB patients with inadequate nucleoside analogue therapy
Date of disclosure of the study information 2010/08/03
Last modified on 2020/03/31 17:43:05

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Basic information

Public title

Randomized control trial of increased dose therapy with Entecavir vursus combination therapy with Entecavir and Adefovir in CHB patients with inadequate nucleoside analogue therapy

Acronym

Compare the value of increased dose to combination therapy with nucleoside analogues

Scientific Title

Randomized control trial of increased dose therapy with Entecavir vursus combination therapy with Entecavir and Adefovir in CHB patients with inadequate nucleoside analogue therapy

Scientific Title:Acronym

Compare the value of increased dose to combination therapy with nucleoside analogues

Region

Japan


Condition

Condition

Chronic hepatitis B

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the antiviral efficacy of increased dose therapy with Entecavir and combination therapy with Entecavir and Adefovir on inadequate nucleoside analogue therapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Improvement of HBcrAg, HBsAg

Key secondary outcomes

safety


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


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Entecavir 0.5mg/day + Adefovir 10mg/day

Interventions/Control_2

Entecavir 1.0mg/day

Interventions/Control_3

Entecavir 0.5mg/day

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

37 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Chronic hepatitis B
Entecavir 0.5mg/day
HBV DNA positive
HBcrAg >=4.0 Log IU/ml
HBsAg >=1000IU/ml

Key exclusion criteria

1. Resistant to Entecavir
2. Intolerance to Entecavir
3. Pregnant, lactating women
4. Possibly pregnant women
5. Chronic kidney failure
6. Creatinine clearance of <=50 mL/ min
7. Severe heart diseases
8. Decompensated liver cirrhosis
9. Liver transplant patient
10. HIV/HBV superinfection

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shuhei Nishiguchi

Organization

Hyogo College Of Medicine

Division name

Division of Hepatobiliary and Pancreatic Diseases Department of Internal Medicine

Zip code


Address

1-1 Mukogawa, Nishinomiya, Hyogo, Japan

TEL

0798-45-6472

Email



Public contact

Name of contact person

1st name
Middle name
Last name Masaki Saito

Organization

Hyogo College Of Medicine

Division name

Division of Hepatobiliary and Pancreatic Diseases Department of Internal Medicine

Zip code


Address

1-1 Mukogawa, Nishinomiya, Hyogo, Japan

TEL

0798-45-6472

Homepage URL


Email

he-jishu@hyo-med.ac.jp


Sponsor or person

Institute

Hyogo College Of Medicine

Institute

Department

Personal name



Funding Source

Organization

Hyogo College Of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Wakakoukai clinic

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

兵庫医科大学病院(兵庫県)


Other administrative information

Date of disclosure of the study information

2010 Year 08 Month 03 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

Terminated

Date of protocol fixation

2010 Year 05 Month 18 Day

Date of IRB

2010 Year 06 Month 04 Day

Anticipated trial start date

2010 Year 08 Month 01 Day

Last follow-up date

2014 Year 05 Month 01 Day

Date of closure to data entry

2014 Year 08 Month 01 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 08 Month 02 Day

Last modified on

2020 Year 03 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004798


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name