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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028834
Receipt No. 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 2017/08/25

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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
Middle name
Last name Masahiko Okada
Organization Nagasaki University Hospital
Division name Department of pediatrics
Zip code
Address 1-7-1Sakamoto, Nagasaki
TEL 095-819-7298
Email mokada@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiko Okada
Organization Nagasaki University Hospital
Division name Department of pediatrics
Zip code
Address 1-7-1Sakamoto, Nagasaki
TEL 095-819-7298
Homepage URL
Email mokada@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2017 Year 08 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
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
2017 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033001

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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