UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007231 |
|---|---|
| Receipt number | R000008518 |
| Scientific Title | Examination of the nucleoside analog-PEG-IFN alpha 2a sequential therapy for Drug Free |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2017/11/13 09:53:28 |
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Basic information
Public title
Examination of the nucleoside analog-PEG-IFN alpha 2a sequential therapy for Drug Free
Acronym
Examination of the nucleoside analog-PEG-IFN alpha 2a sequential therapy for Drug Free
Scientific Title
Examination of the nucleoside analog-PEG-IFN alpha 2a sequential therapy for Drug Free
Scientific Title:Acronym
Examination of the nucleoside analog-PEG-IFN alpha 2a sequential therapy for Drug Free
Region
| Japan |
Condition
Condition
chronic hepatitis B
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety of nucleoside analog-PEG-IFN alpha 2a sequential therapy for the chronic hepatitis B.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
[HBeAg-positive chronic hepatitis B]
This study had two predetermined primary measures of efficacy assessed after 24 weeks of follow up for
1) HBe seroconversion 2) the normalization of alanine aminotransferase levels (below 30IU/L) and the suppression of HBV DNA levels to below 5.0Log copies/ml
[HBeAg-negative chronic hepatitis B] the normalization of alanine aminotransferase levels (below 30IU/L) and the suppression of HBV DNA levels to below 4.0Log copies/ml after 24 weeks of follow up
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
48 weeks of PEG-IFN alpha 2a treatment
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patient with chronic hepatitis B treated with nucleoside analog, just before the trial, HBV DNA less than 2.1 log copies/mL for less than 1 years
2.Patient diagnosed as chronic hepatitis B before PEG-IFN alpha 2a medication, patients were eligible if they had
. a neutrophil count of more than 1500/microliter
. a platelet count of more than 90,000/microliter
. a hemoglobin count of more than 10g/dl
3. The patient in which a liver biopsy is carried out before PEG-IFN alpha 2a medication in principle, and the result is not F4
4. Patients were not eligible if they had a HBs Ag count of more than 3.0 log copies /mL, and HBcrAg count of more than 4.0 log copies /mL in principle
5. Patients who understand fully the contents of the study and obtain agreement with documents for participation in present study by own free will
Key exclusion criteria
1. The patient who has the resistant to nucleic acid analog, such as Lamivudine and Entecavir
2. Severe state of liver damage (the patient who conflicts with two items or more,total bilirubin is more than 2.0 mg/dl, prothrombin time is less than 70 %, and albumin is less than 3.6 g/dl)
3. Other chronic liver disease patients such as autoimmune hepatitis or alcoholic hepatitis
4. Severe state of complication, especially, patients were not eligible if they kept the function of bone marrow, kidney, heart, or respiration
5. Pregnant woman or woman who has possibility of pregnancy or woman while suckling
6. Patient who is administering the sho-sai-ko-to
7. A patient with the previous history of interstitial pneumonia
8. Patient who has previous history of hypersensitivity for element of PEG-IFN alpha 2a or other IFNs
9. Patient who has previous history of hypersensitivity for biological products such as vaccines
10. Patient who exists in serious state of mental disease of serious depression, thought of suicide or suicide plan, etc. or with these history
11. Additionally, patient judged by doctor that participation in this study is improper
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Azuma |
Organization
Department of Internal Medicine, Kobe University Graduate School of Medicine
Division name
Divison of Gastroenterology
Zip code
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
0783826305
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Yano |
Organization
Department of Internal Medicine, Kobe University Graduate School of Medicine
Division name
Divison of Gastroenterology
Zip code
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
0783826305
Homepage URL
yanoyo@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Gastroenterology, Department of Internal Medicine,Kobe University Graduate School of Medicine
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
| 2012 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | 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
| 2012 | Year | 02 | Month | 06 | Day |
Last modified on
| 2017 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008518
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| Registered date | File name |
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| Registered date | File name |
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