UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006659 |
|---|---|
| Receipt number | R000007868 |
| Scientific Title | Examination of efficacy and safety of PEG-IFN alpha-2a plus Adefovir dipivoxil for the treatment of chronic hepatitis B |
| Date of disclosure of the study information | 2012/01/04 |
| Last modified on | 2017/11/13 09:53:17 |
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Basic information
Public title
Examination of efficacy and safety of PEG-IFN alpha-2a plus Adefovir dipivoxil for the treatment of chronic hepatitis B
Acronym
PEG-IFN alpha-2a plus Adefovir therapy for chronic hepatitis B
Scientific Title
Examination of efficacy and safety of PEG-IFN alpha-2a plus Adefovir dipivoxil for the treatment of chronic hepatitis B
Scientific Title:Acronym
PEG-IFN alpha-2a plus Adefovir therapy for 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
To examine the efficacy and safety of PEG-IFN alpha-2a plus Adefovir dipivoxil for the treatment of chronic hepatitis B.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
[HBeAg-positive chronic hepatitis B]
Efficacy assessed after 24 weeks of follow up for HBeAg seroconversion
[HBeAg-negative chronic hepatitis B]
This study had two predetermined primary measures of efficacy assessed after 24 weeks of follow up for
1)the suppression of HBV DNA levels to below 4.3Log copies/ml
2)the normalization of alanine aminotransferase levels (below 40IU/L)
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
Adefovir dipivoxil is administered to the patient in addition to standard treatment of chronic hepatitis B.
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 diagnosed as chronic hepatitis B
2. Before beginning therapy, 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 12g/dl
3. Patient who obtains agreement for participation in present study
Key exclusion criteria
1. Patient who is administering the sho-sai-ko-to
2. A patient with the previous history of interstitial pneumonia
3. Other chronic liver disease patients such as autoimmune hepatitis or alcoholic hepatitis
4. Patient who has previous history of hypersensitivity for element of PEG-IFN alpha-2a or other IFNs
5. Patient who has previous history of hypersensitivity for biological products such as vaccines
6. Patient with cirrhosis, liver failure, and liver carcinoma
7. Hepatic encephalopathy, an esophageal varix, a patient with abdominal dropsy, or a patient with these previous history
8. A patient with autoimmune diseases (hemolytic anemia, chronic ulcerative colitis, rheumatoid arthritis, etc.), or a patient with these anamneses
9. Patient who has heart disease difficult to control (cardiac infarction, cardiac failure, and arrhythmia, etc.)
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. The patient of uncontrollable hypertension
12. A patient with the past of apoplexy (cerebral infarction, cerebral hemorrhage, subarachnoid bleeding, transient ischemic attack)
13. Pregnant woman or woman who has possibility of pregnancy or woman while suckling
14. Additionally, patient judged by doctor that participation in this study is improper
15. The patient who has the resistant to nucleic acid analog, such as Lamivudine and Entecavir
Target sample size
50
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
Gastroenterology
Zip code
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Yano |
Organization
Kobe University Hospital
Division name
Gastroenterology
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-6305
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
Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine
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
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 | 01 | Month | 04 | 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
| 2011 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | 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
| 2011 | Year | 11 | Month | 02 | 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=R000007868
