UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018371 |
|---|---|
| Receipt number | R000021253 |
| Scientific Title | Efficacy of Pegylated interferon treatment for chronic hepatitis B |
| Date of disclosure of the study information | 2015/08/01 |
| Last modified on | 2019/08/02 15:54:38 |
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Basic information
Public title
Efficacy of Pegylated interferon treatment for chronic hepatitis B
Acronym
Efficacy of Pegylated interferon
Scientific Title
Efficacy of Pegylated interferon treatment for chronic hepatitis B
Scientific Title:Acronym
Efficacy of Pegylated interferon
Region
| Japan |
Condition
Condition
patients with chronic hepatitis B infection
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to assess the efficacy of pegylated interferon treatment for chronic hepatitis B
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
probability of HBV DNA negativity
decrease rate of HB surface antigen level
decrease rate of HB core-related antigen
probability of ALT normalization
probability of HBe antigen seroconversion
cumulative incidence rate of hepatocellular carcinoma
Key secondary outcomes
improvement of liver fibrosis
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 with 20 years of age and older
2)HB surface antigen positive for over 6 months
3)patients without cirrhosis
4)baseline hemoglobin over 10 g/dl
5)baseline platelet counts over 90000/microL
6)baseline neutrophil over 1500/microL
Key exclusion criteria
1)pregnant woman
2)co-infection with other hepatitis virus (HCV/HDV/HIV)
3)other liver disease such as autoimmune hepatitis, alcoholic liver disease etc.
4)comorbidity with other severe disease or immune dificiency
5)severe depression or other severe mental disease
6)contraindication for interferon treatment
Target sample size
100
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
Gastroenterology and Hepatology
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka, Japan
TEL
81-6-6879-3621
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
Gastroenterology and Hepatology
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka, Japan
TEL
81-6-6879-3621
Homepage URL
ryo726@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine, Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Research on Hepatitis from Ministry of Health Labour and Welfare of Japan, and Scientific Research from the Ministry of Education, Science, and Culture of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
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
| 2015 | Year | 08 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | 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
To assess the efficacy of pegylated interferon in patients infected with hepatitis B virus. To investigate the relative factors with antiviral effect and suppressive effect of hepatocellular carcinoma.
Management information
Registered date
| 2015 | Year | 07 | Month | 21 | 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=R000021253
