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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000037503 |
Receipt No. | 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 | 2020/02/26 |
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 |
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Condition | ||||
Condition | Hemophilia A | |||
Classification by specialty |
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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 |
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Age-upper limit |
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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). |
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Key exclusion criteria | No criteria | |||
Target sample size | 80 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Chugai Pharmaceutical Co. Ltd. | ||||||
Division name | Real world data science Dept. | ||||||
Zip code | 103-8324 | ||||||
Address | 1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan | ||||||
TEL | 03-3273-0769 | ||||||
nomuramkt@chugai-pharm.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Chugai Pharmaceutical Co. Ltd. | ||||||
Division name | Real world data science Dept. | ||||||
Zip code | 103-8324 | ||||||
Address | 1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan | ||||||
TEL | 03-3273-0905 | ||||||
Homepage URL | |||||||
nomuramkt@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 | 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 |
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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 | Enrolling by invitation | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042752 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |