UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048156 |
|---|---|
| Receipt number | R000054880 |
| Scientific Title | HEMLIBRA Subcutaneous Injection, General drug use-results survey - Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with acquired hemophilia A - |
| Date of disclosure of the study information | 2022/08/01 |
| Last modified on | 2025/01/22 11:44:48 |
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Basic information
Public title
HEMLIBRA Subcutaneous Injection, General drug use-results survey
- Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with acquired hemophilia A -
Acronym
HEMLIBRA Subcutaneous Injection, General drug use-results survey
- Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with acquired hemophilia A -
Scientific Title
HEMLIBRA Subcutaneous Injection, General drug use-results survey
- Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with acquired hemophilia A -
Scientific Title:Acronym
HEMLIBRA Subcutaneous Injection, General drug use-results survey
- Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with acquired hemophilia A -
Region
| Japan |
Condition
Condition
Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with acquired hemophilia A
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To calculate the incidence and periods up to onset of thromboembolic adverse drug reactions when HEMLIBRA is used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with acquired hemophilia A, under conditions of actual clinical use, in order to consider where there is at the greater risk for developing thromboembolic events than clinical trial results.
Safety specifications: Thromboembolic events (Patients with acquired hemophilia A)
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Main survey items etc.
1) Information on facilities
2) Patient demographics
3) Prior treatment history
4) Administration status of HEMLIBRA
5) Factor eight activity and factor eight inhibitor titer prior to HEMLIBRA treatment
6) Factor eight activity and factor eight inhibitor titer after the start of HEMLIBRA
7) APTT measurement or not
8) Concomitant drugs (containing prior treatment), immunosuppressive therapy
9) Combination therapy
10) Adverse events
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with acquired hemophilia A for which HEMLIBRA is scheduled to be used during the enrollment period or was used in facilities where a contract for this surveillance has been concluded.
Key exclusion criteria
None
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Takemoto |
Organization
Chugai Pharmaceutical Co. Ltd.
Division name
Safety science 2 Dept.
Zip code
1038324
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3281-6611
takemotosny@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Murayama |
Organization
Chugai Pharmaceutical Co. Ltd.
Division name
Safety Science 2 Dept.
Zip code
1038324
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3281-6611
Homepage URL
murayamaayk@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co. Ltd.
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
None
Address
None
Tel
None
None
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 | 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
| 2022 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 06 | Month | 24 | Day |
Last modified on
| 2025 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054880
