UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013811
Receipt number R000016121
Scientific Title Effect of nucleosid analog and peginterferon alfa 2a sequential therapy on patients with chronic hepatitis B
Date of disclosure of the study information 2014/05/01
Last modified on 2014/04/25 14:05:01

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Basic information

Public title

Effect of nucleosid analog and peginterferon alfa 2a sequential therapy on patients with chronic hepatitis B

Acronym

Sequential therapy with chronic hepatitis B

Scientific Title

Effect of nucleosid analog and peginterferon alfa 2a sequential therapy on patients with chronic hepatitis B

Scientific Title:Acronym

Sequential therapy with chronic hepatitis B

Region

Japan


Condition

Condition

Chronic hepatitis B

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examination about the ability of drug free to be attained by performing 48 weeks of interferon medication, and a (sequential treatment) for B type chronic hepatitis patient

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

drug free
ALT<40 HBV-DNA<5.0Log/ml

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

peginterferon-alpha2a
entecavir
adefovir dipivoxil
lamivudine

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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

Patient who the nucleic acid analog tablet for 48 or more weeks (entecavir
Adefovir dipivoxil,Lamivudinele) is having medication continued, and presents HBV DNA negativity(less than 2.6 log copy/mL) to B type chronic hepatitis

Key exclusion criteria

1) Patients receiving Chinese herb (sho-sai-ko-to)
2) Patients with history of interstitial pneumonia
3) Patients with auto immune hepatitis
4) Patients with hypersensitivity to interferon
5) Patients with hypersensitivity to biological agents
6) Patients with neutropenia (<1500/mm3), thrombocytopenia (<90000/mm3), or anemia (Hb<12g/dL)
7) Cirrhotic patients
8) Patients with history of HCC
9) Doctors consider inadequate

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Miwa Kawanaka

Organization

Kawasaki Medical school

Division name

General Internal Medicine2

Zip code


Address

2-1-80,Nakasange,Okayamacity Okayama,JAPAN

TEL

086-225-2111

Email

m.kawanaka@med.kawasaki-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Miwa Kawanaka

Organization

Kawasaki Medical school

Division name

General Internal Medicine2

Zip code


Address

2-1-80,Nakasange,Okayamacity Okayama,JAPAN

TEL

086-225-2111

Homepage URL


Email

m.kawanaka@med.kawasaki-m.ac.jp


Sponsor or person

Institute

General Internal Medicine2
Kawasaki Medical School

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


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



Other administrative information

Date of disclosure of the study information

2014 Year 05 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2012 Year 04 Month 27 Day

Date of IRB


Anticipated trial start date

2012 Year 04 Month 27 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 04 Month 25 Day

Last modified on

2014 Year 04 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016121


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name