UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062446 |
|---|---|
| Receipt number | R000070680 |
| Scientific Title | A single-center retrospective study on clinical outcomes after the introduction of caplacizumab for thrombotic thrombocytopenic purpura and an exploratory analysis of risk factors for the ADAMTS13 inhibitor boosting |
| Date of disclosure of the study information | 2026/08/03 |
| Last modified on | 2026/08/03 12:34:39 |
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Basic information
Public title
A single-center retrospective study on clinical outcomes after the introduction of caplacizumab for thrombotic thrombocytopenic purpura and an exploratory analysis of risk factors for the ADAMTS13 inhibitor boosting
Acronym
C-BOOST project
Scientific Title
A single-center retrospective study on clinical outcomes after the introduction of caplacizumab for thrombotic thrombocytopenic purpura and an exploratory analysis of risk factors for the ADAMTS13 inhibitor boosting
Scientific Title:Acronym
C-BOOST project
Region
| Japan |
Condition
Condition
Thrombotic thrombocytopenic purpura
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to comprehensively characterize the clinical characteristics, treatment strategies, and clinical outcomes of patients with thrombotic thrombocytopenic purpura (TTP) diagnosed at our institution between 2014 and 2025. Furthermore, we aim to compare patients treated before and after the introduction of caplacizumab and to exploratorily identify risk factors associated with ADAMTS13 inhibitor boosting under contemporary treatment strategies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is the incidence of ADAMTS13 inhibitor boosting. By establishing the incidence of this event as the primary endpoint, this study aims to determine its baseline risk and to exploratorily identify risk factors by evaluating associations with patient characteristics and treatment-related factors.
Key secondary outcomes
Secondary outcome measures include the number and duration of therapeutic plasma exchange (TPE) sessions, length of intensive care unit (ICU) stay, occurrence of ADAMTS13 inhibitor boosting, time to normalization of ADAMTS13 activity, and bleeding complications.
ADAMTS13 activity and inhibitor titer at diagnosis; comorbidities (including autoimmune diseases), pregnancy status, and history of malignancy.
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
Participants must meet all of the following inclusion criteria:
Patients newly diagnosed with thrombotic thrombocytopenic purpura (TTP) at our institution.
Patients for whom baseline demographic and clinical information can be confirmed from the medical records.
Key exclusion criteria
Patients meeting one or more of the following exclusion criteria will be excluded from the study:
Patients for whom the diagnosis of thrombotic thrombocytopenic purpura (TTP) is considered uncertain based on the available diagnostic data.
Patients who declined participation through the opt-out procedure.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Isao |
| Middle name | |
| Last name | Tawara |
Organization
Graduate School of Medicine, Mie University
Division name
Department of Hematology and Oncology
Zip code
514-8507
Address
2-174, Edobashi, Tsu city, Mie
TEL
059-231-1111
itawara@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihide |
| Middle name | |
| Last name | Nakamura |
Organization
Department of Hematology and Oncology
Division name
Department of Hematology and Oncology
Zip code
514-8507
Address
2-174, Edobashi, Tsu city, Mie
TEL
059-231-1111
Homepage URL
akihide-n@med.mie-u.ac.jp
Sponsor or person
Institute
Department of Hematology and Oncology, Graduate School of Medicine, Mie University
Institute
Department
Personal name
Funding Source
Organization
Department of Hematology and Oncology, Graduate School of Medicine, Mie University
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
Department of Hematology and Oncology, Graduate School of Medicine, Mie University
Address
2-174, Edobashi, Tsu city, Mie
Tel
059-231-5016
akihide-n@med.mie-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
| 2026 | Year | 08 | Month | 03 | 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
12
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
No longer recruiting
Date of protocol fixation
| 2026 | Year | 04 | Month | 13 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center retrospective observational study. Patients newly diagnosed with immune-mediated thrombotic thrombocytopenic purpura (iTTP) at our institution between January 1, 2014, and December 31, 2025, will be retrospectively identified, and their clinical characteristics, treatments, and outcomes will be evaluated using medical records.
Management information
Registered date
| 2026 | Year | 08 | Month | 03 | Day |
Last modified on
| 2026 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070680
