UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030968 |
|---|---|
| Receipt number | R000035360 |
| Scientific Title | Direct-acting antivirals affects B cells secreting platelet-specific autoantibody in patients with chronic hepatitis C. |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2021/07/20 20:06:51 |
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Basic information
Public title
Direct-acting antivirals affects B cells secreting platelet-specific autoantibody in patients with chronic hepatitis C.
Acronym
Direct-acting antivirals affects B cells secreting platelet-specific autoantibody
Scientific Title
Direct-acting antivirals affects B cells secreting platelet-specific autoantibody in patients with chronic hepatitis C.
Scientific Title:Acronym
Direct-acting antivirals affects B cells secreting platelet-specific autoantibody
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the change of B cells secreting platelet-specific autoantibody in patients with chronic hepatitis C after adminstraion of direct-acting antivirals affects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the change of B cells secreting platelet-specific autoantibody after adminstraion of direct-acting antivirals affects
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
adminstraion of direct-acting antivirals affects
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) Chronic hepatitis or cirrhosis patients with HCV
(2) Patients with 20 years of age and older
Key exclusion criteria
(1) Decompensated cirrhosis, Liver failure
(2)patients with hepatic cell carcinoma
(3) Co-infection with hepatitis B virus
Co-infection with anti- humanimmunodeficiency virus
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Haruki |
| Middle name | |
| Last name | Uojima |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL
+81-42-778-8111
kiruha@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Haruki |
| Middle name | |
| Last name | Uojima |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL
+81-42-778-8111
Homepage URL
kiruha@kitasato-u.ac.jp
Sponsor or person
Institute
kitasato University school of medicine
Institute
Department
Personal name
Funding Source
Organization
kitasato University 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
kitasato
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
Tel
+81-42-778-8111
mailtorinri@med.kitasato-u.ac.jp
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
| 2018 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 24 | Day |
Last modified on
| 2021 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035360
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
