UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Inquiry Search clinical trials

Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000048156
Receipt No. 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 2022/08/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Makoto
Middle name
Last name Nomura
Organization Chugai Pharmaceutical Co. Ltd.
Division name Safety science Dept.
Zip code 1038324
Address 1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL 03-3281-6611
Email 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 1038324
Address 1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL 03-3281-6611
Homepage URL
Email haradarus@chugai-pharm.co.jp

Sponsor
Institute Chugai Pharmaceutical Co. Ltd.
Institute
Department

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
Email 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
2022 Year 08 Month 01 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054880

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.