UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011666 |
|---|---|
| Receipt number | R000013639 |
| Scientific Title | Peginterferon or conventional interferon sequential entecavir treatment for hepatitis B e antigen positive chronic hepatitis B patients: a prospective randomized controlled trial |
| Date of disclosure of the study information | 2013/09/09 |
| Last modified on | 2017/09/11 23:30:46 |
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Basic information
Public title
Peginterferon or conventional interferon sequential entecavir treatment for hepatitis B e antigen positive chronic hepatitis B patients: a prospective randomized controlled trial
Acronym
Peginterferon or conventional interferon sequential entecavir treatment
Scientific Title
Peginterferon or conventional interferon sequential entecavir treatment for hepatitis B e antigen positive chronic hepatitis B patients: a prospective randomized controlled trial
Scientific Title:Acronym
Peginterferon or conventional interferon sequential entecavir 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
Efficacy and safety of peginterferon or conventional interferon sequential entecavir treatment for chronic hepatitis B patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The reduction of HBsAg (<1,000 IU/mL) at 48 weeks after initiating entecavir treatment
Key secondary outcomes
1. The following outcomes at 48 weeks after entecavir treatment (a) HBeAg seroconversion rates (b) The reduction of HBV DNA levels (<5.0 logcopies/mL) (c) ALT normal rates (d) HBeAg seroclearance (e) HBsAg seroclearance (f) HBsAg seroconversion
2. Kinetics of HBV DNA levels
3. Kinetics of HBsAg levels
4. Kinetics of HB core-related antigen levels
5. The chenge of immunological markers
6. The regression of liver fibrosis (measured by Fibroscan)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pegiterferon induction arm
Interventions/Control_2
Conventional interferon (natural IFN-alpha) induction arm
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
# Chronic hepatitis B patients with HBeAg positivity
# Twice or more ALT flares
# HBV DNA levels > 4.0 log copies/mL
Key exclusion criteria
1. Prior exposure of interferon, antiviral agents, antitumoral agents, immunosupressive drugs, and radiotherapy within 6 months
2. HCV RNA positivity
3. Complicating other liver disease
4. The diagnosis of Liver cirrhosis, hepatic failure, and liver cancer
5. The history of hepatic encephalopathy, varices bleeding, and ascites
6. Complicating collagen disease
7. The history of interstitial pneumonia
8. Severe heart disease
9. The history of epilepsy
10. The history of depression
11. The history of abnormal thyroid function
12. The history of stroke
13. Severe diabetes
14. The history of malignant tumor within 5 years
15. The history of liver, kidney or bone marrow transplantation
16. Retinopathy
17. blood test abnormality as follows:
(a) neutrophil < 1,500 /mm3
(b) platelets count < 90,000/ mm3
(c) Hb < 10 g/dL
(d) prothrombin time > 20s or < 60%
(e) ALT > 10 times ULN
(f) total bilirubin > 2.0 mg/dL
(g) albmin < 3.2 g/dL
(h) creatinine clearance < 50 mL/min
18. Pregnancy
19. Doctors condider inadequate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Kumada |
Organization
Toranomon Hospital
Division name
Hepatology
Zip code
Address
1-3-1 Kajigaya Takatsu-ku Kawasaki Kanagawa
TEL
044-877-5111
kumahiro@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Hosaka |
Organization
Toranomon Hospital
Division name
Hepatology
Zip code
Address
1-3-1 Kajigaya Takatsu-ku Kawasaki Kanagawa
TEL
044-877-5111
Homepage URL
hosa-p@toranomon.gr.jp
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
Toranomon Hospital
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
| 2013 | Year | 09 | Month | 09 | 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
| 2013 | Year | 08 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 09 | 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 | 09 | Month | 06 | Day |
Last modified on
| 2017 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013639
