UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018020 |
|---|---|
| Receipt number | 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 09:36:44 |
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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
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
mmurata@gim.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of general internal medicine, Kyushu-University hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020671
