UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010594 |
|---|---|
| Receipt number | R000012373 |
| Scientific Title | Nucleotide analog and/or peginterferon alpha-2a therapy for HBeAg-negative chronic hepatitis B. |
| Date of disclosure of the study information | 2013/05/01 |
| Last modified on | 2013/04/25 16:45:07 |
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Basic information
Public title
Nucleotide analog and/or peginterferon alpha-2a therapy for HBeAg-negative chronic hepatitis B.
Acronym
PANACHE
Scientific Title
Nucleotide analog and/or peginterferon alpha-2a therapy for HBeAg-negative chronic hepatitis B.
Scientific Title:Acronym
PANACHE
Region
| Japan |
Condition
Condition
HBeAg-negative chronic hepatitis B
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate efficacy and safety of nucleotide analog therapy and/or peginterferon alpha-2a therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
negative conversion of HBsAg
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
1. patients in which at least two years have passed since nucleotide analog has been administered.
2. patients with a positive HBsAg, a negative HBeAg, less than 2.1 log copies/ml HBV-DNA.
3. patients and thier family who gave informed consent about the risk or benefit of the study.
4. patients who have more than or equal to 1500/mm3 neutrophils, 90,000/mm3 platelets, and 10 g/dl hemoglobins.
Key exclusion criteria
1. patients receiving Shosaikoto.
2. patients with past history of interstitial pneumonitis.
3. patients with past history of hypersensitivity to peginterferon alpha-2a and other interferons.
4. patients with past history of hypersensitivity to biological products
such as vaccine.
5. pregnant women, women who may be expecting a child or lactating woman.
6. patients with chronic renal failure or severe renal dysfunction with less than or equal to 50 mL/min Ccr.
7.patients with severe depression, suicidal thinking or suicide attempt or past history of any of these diseases.
8. patients with severe liver dysfunction.
9. patients with chronic hepatitis such as autoimmune hepatitis and alcoholic hepatitis.
10. patients judged as inappropriate by the attending physician.
11. patients with less than 1.9 LogIU/mL HBsAg and less than 2.9LogIU/mL HBcrAg.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Sato |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Medicine and Molecular Science
Zip code
Address
3-39-22 Showa-machi, Maebashi, Gunma, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Medicine and Molecular Science
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Gunma University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Gunma University Graduate School of Medicine
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 | 05 | 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
| 2013 | Year | 04 | Month | 24 | 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
The study is underway.
Management information
Registered date
| 2013 | Year | 04 | Month | 25 | Day |
Last modified on
| 2013 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012373
