UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007928 |
|---|---|
| Receipt number | R000009333 |
| Scientific Title | Peginterferon(PEG-IFN) alfa-2a in chronic hepatitis B patients with nucleos(t)ide analogues (NA) treatment |
| Date of disclosure of the study information | 2012/05/10 |
| Last modified on | 2017/11/13 18:47:50 |
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Basic information
Public title
Peginterferon(PEG-IFN) alfa-2a in chronic hepatitis B patients with nucleos(t)ide analogues (NA) treatment
Acronym
PEG-IFN for NA-experienced CH-B
Scientific Title
Peginterferon(PEG-IFN) alfa-2a in chronic hepatitis B patients with nucleos(t)ide analogues (NA) treatment
Scientific Title:Acronym
PEG-IFN for NA-experienced CH-B
Region
| Japan |
Condition
Condition
Nucleoside analogue experienced patients infected with hepatitis B virus infection
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To examine the safety and efficacy in peginterferon alfa-2a therapy in Japanese NA-experienced patients infected with hepatitis B virus (HBV)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HBV DNA and ALT levels at 24 week after stopping the treatment
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 were eligible if they met the following inclusion criteria: (i) infected with HBV alone, (ii) age =>20 years, (iii) diagnosed as chronic hepatitis B, (iv) WBC =>3000/mm3 , (v) neutrophils =>1500/mm3, (vi) platelets =>90000/mm3, (vii) hemoglobin => 12 g/dL, (viii) Doctors judged patient as appropriate person in this trial , (ix) patients experienced with NA, (x)HBV DNA levels < 3 log IU/mL, (xi) no or mild hepatic fibrosis, (xii) patient and his/her family underst and well this disease and treatment.
Key exclusion criteria
1) Pregnancy
2) Severe liver diseases
3) Cirrhosis or hepatic failure such as chronic liver diseases, e.g. autoimmune hepatitis and alcoholic hepatitis
4) Severe other diseases
5) History of pneumonitis
6) Past-history of hypersensitivity against interferon or peginterferon, etc.
7) Severe mental disorders
8) Abnormal hematological exams
9) Past-history of hypersensitivity against vaccination, etc.
10) Under treatment of TJ-9
11) Doctor judged patient as inappropriate person in this trial
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Yokosuka, M.D. |
Organization
Chiba University, Graduate School of Medicine
Division name
Department of Gastroenterology and Nephrology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan (260-8677)
TEL
043-226-2086
kandat-cib@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuo Kanda, M.D. |
Organization
Chiba University, Graduate School of Medicine
Division name
Department of Gastroenterology and Nephrology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan (260-8677)
TEL
043-226-2086
Homepage URL
kandat-cib@umin.ac.jp
Sponsor or person
Institute
Chiba University, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Chiba 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
Chiba University Hospital (Chiba, JPN)
千葉大学医学部附属病院(千葉県)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 03 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 11 | Month | 11 | Day |
Date trial data considered complete
| 2017 | Year | 11 | Month | 11 | Day |
Date analysis concluded
| 2017 | Year | 11 | Month | 11 | Day |
Other
Other related information
In future, we will perform the observation study.
Management information
Registered date
| 2012 | Year | 05 | Month | 10 | 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=R000009333
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