UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000032717 |
|---|---|
| Receipt number | R000026223 |
| Scientific Title | Usefulness of Add-on Therapy of Pegylated Interferon alfa2a with Nucleoside/nucleotide Analog Treatment for Patients with Hepatitis B Virus Infection |
| Date of disclosure of the study information | 2018/05/25 |
| Last modified on | 2021/05/28 23:14:54 |
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Basic information
Public title
Usefulness of Add-on Therapy of Pegylated Interferon alfa2a with Nucleoside/nucleotide Analog Treatment for Patients with Hepatitis B Virus Infection
Acronym
Add-on therapy of PegIFN-alfa2a with NA treatment
Scientific Title
Usefulness of Add-on Therapy of Pegylated Interferon alfa2a with Nucleoside/nucleotide Analog Treatment for Patients with Hepatitis B Virus Infection
Scientific Title:Acronym
Add-on therapy of PegIFN-alfa2a with NA treatment
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 improve the success rate of discontinuation of nucleoside/nucleotide analog by add-on therapy with pegylated interferon aifa-2a with nucleotide analog treatment for patients with HBV infection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is achievement rate of discontinuation of NA until 5 years after add-on therapy.
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
PegIFN alfa-2a (Pegasys) once 90 or 180 micrograms, administered 48 times per week
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
HBe antigen-negative and anti-HBc positive
serum HBV-DNA levels were undetective; under 2.1 log copies/ml (20 IU/ml)
more than 80 IU/mL of HBs antigen levels or more than 3.0 log U/ml of HBcrAg levels
Key exclusion criteria
Cirrhosis
HCC
During pregnancy
Mental illness merger
Minor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Mochida |
Organization
Saitama Medical University
Division name
Department of Gastroenterology & Hepatology
Zip code
3500495
Address
38 Morohongo, Moroyama-cho, Iruma-gun, 350-0495 Saitama, Japan
TEL
+81(0)49-276-1198
smochida@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Mochida |
Organization
Saitama Medical University
Division name
Department of Gastroenterology & Hepatology
Zip code
3500495
Address
38 Morohongo, Moroyama-cho, Iruma-gun, 350-0495 Saitama, Japan
TEL
+81(0)49-276-1198
Homepage URL
smochida@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University, Department of Gastroenterology & Hepatology
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University, Department of Gastroenterology & Hepatology
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
The Institutional Review Board of Saitama Medical University Hospital
Address
38 Morohongo, Moroyama-cho, Iruma-gun, 350-0495 Saitama, Japan
Tel
049-276-1354
hirb@saitama-med.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
| 2018 | Year | 05 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
26
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 25 | Day |
Last modified on
| 2021 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026223
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
