UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012415 |
|---|---|
| Receipt number | R000011457 |
| Scientific Title | Effect of switching therapy from nucleos(t)ide analogue to pegylated-interferon in patients with chronic hepatitis B |
| Date of disclosure of the study information | 2013/11/27 |
| Last modified on | 2019/08/02 15:22:20 |
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Basic information
Public title
Effect of switching therapy from nucleos(t)ide analogue to pegylated-interferon in patients with chronic hepatitis B
Acronym
Effect of switching therapy from nucleos(t)ide analogue to pegylated-interferon in patients with chronic hepatitis B
Scientific Title
Effect of switching therapy from nucleos(t)ide analogue to pegylated-interferon in patients with chronic hepatitis B
Scientific Title:Acronym
Effect of switching therapy from nucleos(t)ide analogue to pegylated-interferon in patients with 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
Nucleos(t)ide analogues (NAs) have been used generally for patients with chronic hepatitis B, but they have no effect on intrahepatic HBV (cccDNA), leading to recurrence of hepatitis after cessation of NAs. Moreover, little is known about the suppressive effect of NA treatment for developing hepatocellular carcinoma (HCC). On the other hand, interferon has a weak effect on HBV reproduction inhibition, but has immunomodulatory effects, with antiviral effects persisting after completion of administration. The aim of this study is to investigate the antiviral effect and suppressive effect on incidence of HCC in patients with chronic hepatitis B by switching therapy from NAs to pegylated interferon.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
decline rate of HB surface antigen, loss of HB surface antigen
decline rate of HB core-related antigen
suppression of HBV DNA (< 4 log copies/mL)
ALT normalization
HBe antigen seroconversion (among patients with HBe antigen)
at 24 and 48 weeks after completing pegylated interferon 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
drug: PegIFN alfa 2a
duration: PegIFN alfa 2a and nucleos(t)ide analogue combination therapy for 12 weeks and monotherapy of PegIFN alfa 2a for 36 weeks
dose: PegIFN alfa 2a 90-180mcg s.c. weekly
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
patients with chronic hepatitis B treated with nucleos(t)ide analogue and HBV DNA < 4 log copies/mL for more than 1 year
Key exclusion criteria
under age of 20
significant liver fibrosis (F3-)
coinfection with HCV / HDV / HIV
coexistence with other chronic liver disease
pregnant or breast-feeding women
contraindication to scheduled drugs
patients found to be inadequate by their doctors
Target sample size
200
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
Department of Gastroenterology and Hepatology
Zip code
565-0871
Address
2-2, Yamadaoka, Suita City, Osaka
TEL
06-6879-3621
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
Department of Gastroenterology and Hepatology
Zip code
565-0871
Address
2-2, Yamadaoka, Suita City, Osaka
TEL
06-6879-3621
Homepage URL
ryo726@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2013 | Year | 11 | Month | 27 | 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
| 2013 | Year | 04 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | 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
| 2013 | Year | 11 | Month | 27 | 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=R000011457
