UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037503 |
|---|---|
| Receipt number | R000042752 |
| Scientific Title | HEMLIBRA Subcutaneous injection Special Drug Use Surveillance (with Hemophilia A without Inhibitors). |
| Date of disclosure of the study information | 2019/07/27 |
| Last modified on | 2022/01/18 10:52:20 |
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Basic information
Public title
HEMLIBRA Subcutaneous injection Special Drug Use Surveillance (with Hemophilia A without Inhibitors).
Acronym
HEMLIBRA Special Drug Use Surveillance (with Hemophilia A without Inhibitors).
Scientific Title
HEMLIBRA Subcutaneous injection Special Drug Use Surveillance (with Hemophilia A without Inhibitors).
Scientific Title:Acronym
HEMLIBRA Special Drug Use Surveillance (with Hemophilia A without Inhibitors).
Region
| Japan |
Condition
Condition
Hemophilia A
Classification by specialty
| Hematology and clinical oncology | Pediatrics | Blood transfusion |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm dose and type of factor VIII agents (hereinafter, called "FVIII") with HEMLIBRA and thrombotic events which may be related to co-administration of FVIII.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. The incidence of thrombotic ADR in patients with FVIII agents.
2. The incidence (time to onset, outcome, treatment state) of thrombotic ADR (thromboembolisms and thrombotic microangiopathy).
3. Dose (type, duration, dosage, reason of administration) of FVIII and HEMLIBRA in patient with thrombotic ADR (thromboembolisms and thrombotic microangiopathy) .
4. Dose (class, duration, dosage, reason of administration) of FVIII in 1 year from first HEMLIBRA administration.
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
Patients in contracted site meet all of the following criteria 1) to 3).
1) Patients with Hemophilia A without Inhibitors.
2) Patients who receive first HEMLIBRA administration from June, 2019 to June, 2020 (exclude previous administration history in other sites).
3) Patients who receive FVIII in follow up period (except for patients who receive only FVIII as regular continuous replacement therapy until a day before second dose of HEMLIBRA).
Key exclusion criteria
No criteria
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Nomura |
Organization
Chugai Pharmaceutical Co. Ltd.
Division name
Safety science Dept.
Zip code
103-8324
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3281-6611
nomuramkt@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Ryousuke |
| Middle name | |
| Last name | Harada |
Organization
Chugai Pharmaceutical Co. Ltd.
Division name
Safety science Dept.
Zip code
103-8324
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3281-6611
Homepage URL
haradarus@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
N/A
Address
N/A
Tel
N/A
N/A
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
| 2019 | Year | 07 | Month | 27 | 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
87
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
| 2019 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Dose and type of factor VIII agents (hereinafter, called "FVIII") with HEMLIBRA and thrombotic events which may be related to co-administration of FVIII.
Management information
Registered date
| 2019 | Year | 07 | Month | 26 | Day |
Last modified on
| 2022 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042752
