UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039069 |
|---|---|
| Receipt number | R000044559 |
| Scientific Title | Survey of anti-AAV neutralizing antibody prevalence in hemophiliacs and healthy adults |
| Date of disclosure of the study information | 2020/01/10 |
| Last modified on | 2022/06/22 16:11:56 |
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Basic information
Public title
To investigate the prevalence of neutralizing antibodies against adeno-associated virus in hemophiliacs and healthy adults
Acronym
Survey to investigate the prevalence of neutralizing antibody against anti-adeno-associated virus
Scientific Title
Survey of anti-AAV neutralizing antibody prevalence in hemophiliacs and healthy adults
Scientific Title:Acronym
Survey of anti-AAV neutralizing antibody prevalence
Region
| Japan |
Condition
Condition
hemophiliacs and healthy adults
Classification by specialty
| Hematology and clinical oncology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the prevalence of anti-AAV neutralizing antibody in hemophiliacs and healthy adults in Japan
Basic objectives2
Others
Basic objectives -Others
Measurement of anti-AAV neutralizing antibody titer
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The titer and prevalence of anti-AAV neutralizing antibody against several AAV serotypes
Key secondary outcomes
1) Establishment of method to measure anti-AAV neutralizing antibody
2) Association of the prevalence of anti-AAV neutralizing antibody with age, gender, facility, and type of blood coagulation factor used for the therapy
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
A single blood collection
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
| 10 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Male hemophilia over 10 years old
2) Healthy adults at 20 to 69 years old
Key exclusion criteria
1) The person who cannot obtain informed consent
2) Those who are treated with antibody drugs
3) Those who are treated by systemic administration of immunosuppressants (oral and injection)
4) Patients with the possibility of immunological abnormalities such as severe inflammatory diseases
5)The person judged to be ineligible by the investigator
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Tsukasa |
| Middle name | |
| Last name | Ohmori |
Organization
Jichi Medical University
Division name
Department of Biochemistry
Zip code
3290498
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan 329-0498
TEL
0285-58-7324
tohmori@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Tsukasa |
| Middle name | |
| Last name | Ohmori |
Organization
Jichi Medical University
Division name
Department of Biochemistry
Zip code
3290498
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan 329-0498
TEL
0285-58-7324
Homepage URL
tohmori@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ogikubo Hospital
Tokyo Medical University Hospital
The University of Tokyo Hospital
Research Hospital The Institute of Medical Science The University of Tokyo
National Center for Global Health and Medicine
St. Marianna University School of Medicine
Nagoya University Hospital
Mie University Hospital
Nara Medical University Hospital
The Hospital of Hyogo College of Medicine
Hiroshima University Hospital
Ehime University Hospital
Munakata Suikokai General Hospital
Shizuoka Children's Hospital
Mitsubishi Tanabe Pharma Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee-A
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan 329-0498
Tel
0285-58-8933
rinri@jichi.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
| 2020 | Year | 01 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://medrxiv.org/cgi/content/short/2022.06.16.22276528v1
Number of participants that the trial has enrolled
227
Results
The Seroprevalence of anti-AAV neutralizing antibody for various AAV serotypes was 22.2% for AAV1, 24.5% for AAV2, 29.2% for AAV3B, 22.7% for AAV5, 23.1% for AAV6, 24.1% for AAV7, 20.4% for AAV8, 21.3% for AAV9 and 23.6% for AAVrh10. There was no clear difference in the positivity rates between healthy subjects and hemophiliacs.
Results date posted
| 2022 | Year | 06 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
hemophiliacs and healthy adults
Participant flow
1. Patients with hemophilia were informed of the purpose of the study. Written informed consent wad obtained from all participants. An extra 10 mL of blood was drawn in addition to their usual medical care. The following information was obtained: facility name, age, disease name (hemophilia A or B), minimum coagulation factor activity level, severity of hemophilia, name of coagulation factor preparation, and concomitant infection with HBV, HCV, and HIV.
2. Healthy adult volunteers were informed of the purpose of the study. Written informed consent was obtained from all participants, and then 10 mL of blood was drawn. Information on age, gender, and concomitant infection with HBV, HCV, and HIV were obtained.
Adverse events
No adverse events
Outcome measures
The Seroprevalence of anti-AAV neutralizing antibodies positive for each AAV serotype
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 07 | Day |
Last modified on
| 2022 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044559
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