UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047344 |
|---|---|
| Receipt number | R000053996 |
| Scientific Title | Nuwiq for i.v. injection Drug use-result survey |
| Date of disclosure of the study information | 2022/03/31 |
| Last modified on | 2022/04/07 08:23:00 |
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Basic information
Public title
Nuwiq for i.v. injection Drug use-result survey
Acronym
Nuwiq for i.v. injection Drug use-result survey
Scientific Title
Nuwiq for i.v. injection Drug use-result survey
Scientific Title:Acronym
Nuwiq for i.v. injection Drug use-result survey
Region
| Japan |
Condition
Condition
Hemophilia A
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Purpose is to understand the safety and efficacy of Nuwiq (hereinafter referred to as "this drug") in patients with blood coagulation factor VIII deficiency.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety (Incidence of adverse reactions,Inhibitor development,Incidence of shock, anaphylactic reactions,Factors that may influence on safety)
Key secondary outcomes
Efficacy (Bleeding rate,Hemostasis evaluation)
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
This drug administered patients with blood coagulation factor VIII (Haemophilia A) deficiency.
Key exclusion criteria
NA
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Chikako |
| Middle name | |
| Last name | Nakao |
Organization
Fujimoto Pharmaceutical Corp.
Division name
Department of Pharmacovigilance
Zip code
580-8503
Address
1-3-40, Nishiotsuka, Matsubara, Osaka 580-8503, Japan
TEL
072-332-5151
pms@fujimoto-pharm.co.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Kitada |
Organization
Fujimoto Pharmaceutical Corp.
Division name
Department of Pharmacovigilance
Zip code
580-8503
Address
1-3-40, Nishiotsuka, Matsubara, Osaka 580-8503, Japan
TEL
072-332-5151
Homepage URL
pms@fujimoto-pharm.co.jp
Sponsor or person
Institute
Fujimoto Pharmaceutical Corp.
Institute
Department
Personal name
Funding Source
Organization
Fujimoto Pharmaceutical Corp.
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
Not applicable
Address
Not applicable
Tel
Not applicable
Not applicable
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 | 03 | Month | 31 | 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 | 02 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Approval by IRB is not necessary.
Management information
Registered date
| 2022 | Year | 03 | Month | 31 | Day |
Last modified on
| 2022 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053996
