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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018020
Receipt No. R000020671
Scientific Title Analysis for the efficacy and safety of peginterferon-alpha-2a monotherapy on chronic active hepatitis B patients
Date of disclosure of the study information 2015/06/23
Last modified on 2017/12/23

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Basic information
Public title Analysis for the efficacy and safety of peginterferon-alpha-2a monotherapy on chronic active hepatitis B patients
Acronym Peginterferon-alpha-2a monotherapy in patients with chronic hepatitis B
Scientific Title Analysis for the efficacy and safety of peginterferon-alpha-2a monotherapy on chronic active hepatitis B patients
Scientific Title:Acronym Peginterferon-alpha-2a monotherapy in patients with chronic hepatitis B
Region
Japan

Condition
Condition Chronic hepatitis B
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy and safety of peginterferon-alpha-2a monotherapy in patients with chronic active hepatitis B.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes <Efficacy>
A. In patients with HBe Ag positive chronic hepatitis B at the start of therapy.
At the 24 weeks after the end of therapy
1. The proportion of patients with HBe Ag seroconvertsion.
2. The proportion of patients achieving HBV DNA less than 5.0 log copies/mL.
3. The proportion of patients achieving ALT 40 U/L and fewer.

B. In patients with HBe Ag negative chronic hepatitis B at the start of therapy.
At the 24 weeks after the end of therapy
1. The proportion of patients achieving HBV DNA less than 4.3 log copies/mL
2. The proportion of patients achieving ALT 40 U/L and fewer.

<Safety>
1. Adverse events, clinical laboratory tests (the changes in neutrophil and , platelet counts, hemoglobin levels)
2. Treatment continuation, reduction, and discountinuation rates, the reason for discontinuation of 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 Peg-interferon alpha-2a (Pegasys) 180 microg/week subcutaneously for 48 weeks
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 1. Patients aged 20 years old and over.
2. Patients with chronic hepatitis B.
3. Patients who meet the following conditions before the start of therapy.
A. Neutrophil counts; 1,500 microliter and over.
B. Platelet counts; 90,000 microliter and over.
C. Hemoglobin concentrations; 10 g/dL and over.
4. Patients who is explained well about this study and is obtained signed informed consent form to this study with free will.
Key exclusion criteria Patients with the following are excluded:
1. Patients who are taking herbal medicine, syo-saiko-to.
2. Previous history of interstitial pneumonia.
3. Other chronic liver diseases such as autoimmune hepatitis, alcoholic liver disease.
4. Previous history of hypersensitivity to peginterferon-alpha-2a or other interferon products.
5. Previous history of hypersensitivity to biologicals such as vaccines.
6. Liver cirrhosis, liver failure and hepatocellular carcinoma.
7. Patients who have hepatic encephalaopathy, esophageal varices, ascites, or those previous history.
8. Patients who have autoimmune diseases such as hemolytic anemia, ulcerative colitis, rheumatoid arthritis, or those previous history.
9. Patients who have heart diseases difficult to control.
10. Patients who have depression, epileptic seizure, or mental disorders with continuous treatment, or those previous history.
11. Uncontrollable hypertension.
12. Previous history of cerebrovascular diseases such as brain infarction, cerebral hemorrhage, subarachnoid hemorrhage or transient ischemic attack.
13. Diabetes mellitus receiving medical treatment.
14. Patients who are pregnant or lactating women.
15. Patients who are receiving nucleotide analogues treatments within three months.
16. Patients who are disquialified to participate in this trial judged by attending physician.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiro Furusyo
Organization Kyushu University Hospital
Division name Department of general internal medicine
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL 092-642-5909
Email furusyo@gim.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayuki Murata
Organization Kyushu University Hospital
Division name Department of general internal medicine
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL 092-642-5909
Homepage URL
Email mmurata@gim.med.kyushu-u.ac.jp

Sponsor
Institute Department of general internal medicine, Kyushu-University hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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
2015 Year 06 Month 23 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 Completed
Date of protocol fixation
2013 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 24 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
2015 Year 06 Month 22 Day
Last modified on
2017 Year 12 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020671

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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