UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048635 |
|---|---|
| Receipt number | R000055404 |
| Scientific Title | Cross-reactivity analysis against recombinant porcine FVIII using Japanese acquired hemophilia A patients' plasma samples |
| Date of disclosure of the study information | 2022/08/09 |
| Last modified on | 2024/11/14 19:52:39 |
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Basic information
Public title
Cross-reactivity analysis against recombinant porcine FVIII using Japanese acquired hemophilia A patients' plasma samples
Acronym
Cross-reactivity analysis against recombinant porcine FVIII using Japanese acquired hemophilia A patients' plasma samples
Scientific Title
Cross-reactivity analysis against recombinant porcine FVIII using Japanese acquired hemophilia A patients' plasma samples
Scientific Title:Acronym
Cross-reactivity analysis against recombinant porcine FVIII using Japanese acquired hemophilia A patients' plasma samples
Region
| Japan |
Condition
Condition
Acquired Hemophilia A
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To indicate the Japanese acquired hemophilia A (AHA) patients' reactivity of TAK-672 by measuring anti-recombinant porcine FVIII (rpFVIII) antibody titer in the Japanese AHA patients' plasma and calculating the cross-reactivity
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Cross-reacting against rpFVIII in acquired hemophilia A
Key secondary outcomes
Not applicable
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The plasma samples of patients with AHA who were diagnosed and the informed consent was obtained from in the form of opt-out at Nara Medical University
Key exclusion criteria
Not applicable
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Keiji |
| Middle name | |
| Last name | Nogami |
Organization
Nara Medical University
Division name
Department of Pediatrics
Zip code
634-8521
Address
840, Shijo-cho, Kashihara, Nara, 634-8521, Japan
TEL
0744-29-8881
pediatrics@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuo |
| Middle name | |
| Last name | Miyaguchi |
Organization
Takeda Pharmaceutical Company Limited.
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho, 2-Chome, Chuo-ku, Tokyo, 103-8668, Japan
TEL
070-4921-7966
Homepage URL
yasuo.miyaguchi@takeda.com
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited.
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University Ethics Committee
Address
840, Shijo-cho, Kashihara, Nara, 634-8521, Japan
Tel
0744-22-3051
ino_rinri@naramed-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
| 2022 | Year | 08 | Month | 09 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s12185-024-03854-5
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s12185-024-03854-5
Number of participants that the trial has enrolled
16
Results
Nine of 16 plasma samples (56.3%) had positive pFVIII-INH, with a median cross-reactivity of 1.2%. FVIII activity (FVIII:C) was restored to > 100% in all samples upon spiking with rpFVIII.
Results date posted
| 2024 | Year | 11 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 10 | Month | 30 | Day |
Baseline Characteristics
Patients with Acquired Hemophilia A (PwAHA)
Participant flow
Previously collected and stored plasma samples from Japanese PwAHA were used for this study. Patients had agreed to future use of their plasma samples by Nara Medical University, and measurements for this study were performed after website opt-out in compliance with the Japanese Ethical Guidelines. Plasma samples were obtained between January 2011 and April 2022 and stored at below -80 degrees Celsius until the assay measurements.
Adverse events
N/A
Outcome measures
Cross-reactivity to rpFVIII (anti-pFVIII inhibitor titer/anti-humman FVIII inhibitor titer)
Coagulation Potential of Patient Plasma after spiking rpFVIII (FVIII activity, thrombin generation assay, clot waveform analysis)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2022 | Year | 08 | Month | 09 | Day |
Last modified on
| 2024 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055404
