UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028834 |
|---|---|
| Receipt number | R000033001 |
| Scientific Title | Multicenter observation study to examine the usefulness of transgenic blood coagulation factor VIII Fc fusion protein (rFVIIIFc) preparation for domestic pediatric hemophilia A patients |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2023/03/07 14:53:04 |
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Basic information
Public title
Multicenter observation study to examine the usefulness of transgenic blood coagulation factor VIII Fc fusion protein (rFVIIIFc) preparation for domestic pediatric hemophilia A patients
Acronym
Fc Adolescent and Children Treatment study (FACTs)
Scientific Title
Multicenter observation study to examine the usefulness of transgenic blood coagulation factor VIII Fc fusion protein (rFVIIIFc) preparation for domestic pediatric hemophilia A patients
Scientific Title:Acronym
Fc Adolescent and Children Treatment study (FACTs)
Region
| Japan |
Condition
Condition
hemophilia A
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study the usefulness of rFVIIIFc for children with haemophilia (hemophilia A) based on real clinical practice in Japan
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of annual spontaneous bleeding episodes over 2 years from registration
Key secondary outcomes
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Blood coagulation preparation rFVIIIFc
over 2 years
25-65 IU/kg/dose
The dosing interval ranges from 3 to 5 days
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
| 0 | years-old | < |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Hemophilia A patients who are planning to administer rFVIIIFc or have started administration within the past 12 months
Key exclusion criteria
Patients who are unable or unwilling to provide informed consent
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Yasutomo |
| Middle name | |
| Last name | Funakoshi |
Organization
Nagasaki University Hospital
Division name
Department of pediatrics
Zip code
853-8501
Address
1-7-1Sakamoto, Nagasaki
TEL
095-819-7298
funakoshi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasutomo |
| Middle name | |
| Last name | Funakoshi |
Organization
Nagasaki University Hospital
Division name
Department of pediatrics
Zip code
852-8501
Address
1-7-1Sakamoto, Nagasaki
TEL
095-819-7298
Homepage URL
funakoshi@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Bioverativ Japan 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
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1Sakamoto, Nagasaki
Tel
0958197229
gaibushikin@ml.nagasaki-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
| 2017 | Year | 09 | 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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 25 | Day |
Last modified on
| 2023 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033001
