UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012415
Receipt number R000011457
Scientific Title Effect of switching therapy from nucleos(t)ide analogue to pegylated-interferon in patients with chronic hepatitis B
Date of disclosure of the study information 2013/11/27
Last modified on 2019/08/02 15:22:20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effect of switching therapy from nucleos(t)ide analogue to pegylated-interferon in patients with chronic hepatitis B

Acronym

Effect of switching therapy from nucleos(t)ide analogue to pegylated-interferon in patients with chronic hepatitis B

Scientific Title

Effect of switching therapy from nucleos(t)ide analogue to pegylated-interferon in patients with chronic hepatitis B

Scientific Title:Acronym

Effect of switching therapy from nucleos(t)ide analogue to pegylated-interferon in patients 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

Nucleos(t)ide analogues (NAs) have been used generally for patients with chronic hepatitis B, but they have no effect on intrahepatic HBV (cccDNA), leading to recurrence of hepatitis after cessation of NAs. Moreover, little is known about the suppressive effect of NA treatment for developing hepatocellular carcinoma (HCC). On the other hand, interferon has a weak effect on HBV reproduction inhibition, but has immunomodulatory effects, with antiviral effects persisting after completion of administration. The aim of this study is to investigate the antiviral effect and suppressive effect on incidence of HCC in patients with chronic hepatitis B by switching therapy from NAs to pegylated interferon.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

decline rate of HB surface antigen, loss of HB surface antigen
decline rate of HB core-related antigen
suppression of HBV DNA (< 4 log copies/mL)
ALT normalization
HBe antigen seroconversion (among patients with HBe antigen)
at 24 and 48 weeks after completing pegylated interferon treatment

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

drug: PegIFN alfa 2a
duration: PegIFN alfa 2a and nucleos(t)ide analogue combination therapy for 12 weeks and monotherapy of PegIFN alfa 2a for 36 weeks
dose: PegIFN alfa 2a 90-180mcg s.c. weekly

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

patients with chronic hepatitis B treated with nucleos(t)ide analogue and HBV DNA < 4 log copies/mL for more than 1 year

Key exclusion criteria

under age of 20
significant liver fibrosis (F3-)
coinfection with HCV / HDV / HIV
coexistence with other chronic liver disease
pregnant or breast-feeding women
contraindication to scheduled drugs
patients found to be inadequate by their doctors

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

Department of Gastroenterology and Hepatology

Zip code

565-0871

Address

2-2, Yamadaoka, Suita City, Osaka

TEL

06-6879-3621

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

Department of Gastroenterology and Hepatology

Zip code

565-0871

Address

2-2, Yamadaoka, Suita City, Osaka

TEL

06-6879-3621

Homepage URL


Email

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


Sponsor or person

Institute

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

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

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

2013 Year 11 Month 27 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

2013 Year 04 Month 11 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 01 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

2013 Year 11 Month 27 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=R000011457


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name