UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006649
Receipt number R000007863
Scientific Title Examination of efficacy and safety of PEG-IFN alpha-2a for the treatment of chronic hepatitis B.
Date of disclosure of the study information 2012/01/04
Last modified on 2017/11/13 09:53:07

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Basic information

Public title

Examination of efficacy and safety of PEG-IFN alpha-2a for the treatment of chronic hepatitis B.

Acronym

PEG-IFN alpha-2a therapy for chronic hepatitis B.

Scientific Title

Examination of efficacy and safety of PEG-IFN alpha-2a for the treatment of chronic hepatitis B.

Scientific Title:Acronym

PEG-IFN alpha-2a therapy for 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

To examine the efficacy and safety of PEG-IFN alpha 2a for the treatment of chronic hepatitis B.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

[HBeAg-positive chronic hepatitis B]
Efficacy assessed after 24 weeks of follow up for
1)HBeAg seroconversion
2)the normalization of alanine aminotransferase levels (below 30IU/L), and the suppression of HBV DNA levels to below 5.0Log copies/ml
[HBeAg-negative chronic hepatitis B]
Efficacy assessed after 24 weeks of follow up for
1)the suppression of HBV DNA levels to
below 4.3Log copies/ml
2)the normalization of alanine aminotransferase levels (below 40IU/L)
3)the normalization of alanine aminotransferase levels (below 30IU/L), and the suppression of HBV DNA levels to below 4.0Log copies/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

PEG-IFN alpha-2a for the treatment of chronic hepatitis B

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patient diagnosed as chronic hepatitis B
2.Before beginning therapy, patients were eligible if they had
. a neutrophil count of more than 1500/microliter
. a platelet count of more than 90,000/microliter
. a hemoglobin count of more than 12g/dl
. Patient who obtains agreement for participation in present study

Key exclusion criteria

1.Patient who is administering the sho-sai-ko-to
2.A patient with the previous history of interstitial pneumonia
3.Other chronic liver disease patients such as autoimmune hepatitis or alcoholic hepatitis
4.Patient who has previous history of hypersensitivity for element of PEG-IFN alpha-2a or other IFNs
5.Patient who has previous history of hypersensitivity for biological products such as vaccines
6.Patient with cirrhosis, liver failure, and liver carcinoma
7.Hepatic encephalopathy, an esophageal varix, a patient with abdominal dropsy, or a patient with these previous history
8.A patient with autoimmune diseases (hemolytic anemia, chronic ulcerative colitis, rheumatoid arthritis, etc.), or a patient with these anamneses
9. Patient who has heart disease difficult to control (cardiac infarction, cardiac failure, and arrhythmia, etc.)
10. Patient who exists in serious state of mental disease of serious depression, thought of suicide or suicide plan, etc. or with these history
11. The patient of uncontrollable hypertension
12. A patient with the past of apoplexy (cerebral infarction, cerebral hemorrhage, subarachnoid bleeding, transient ischemic attack)
13. Pregnant woman or woman who has possibility of pregnancy or woman while suckling
14. Additionally, patient judged by doctor that participation in this study is improper

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takeshi Azuma

Organization

Department of Internal Medicine, Kobe University Graduate School of Medicine

Division name

Gastroenterology

Zip code


Address

7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Yoshihiko Yano

Organization

Kobe University Hospital

Division name

Gastroenterology

Zip code


Address

7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan

TEL

078-382-6305

Homepage URL


Email

yanoyo@med.kobe-u.ac.jp


Sponsor or person

Institute

Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine

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

2012 Year 01 Month 04 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

2011 Year 11 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 12 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

2011 Year 11 Month 01 Day

Last modified on

2017 Year 11 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007863


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name