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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006649
Receipt No. 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

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

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
URL(English) https://upload.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


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