A Study of Standard and Individualized Prophylactic Treatment With Advate in Men and Boys With Severe Hemophilia A
NCT ID: NCT04953000
Last Updated: 2023-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
94 participants
OBSERVATIONAL
2021-08-19
2023-04-04
Brief Summary
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No study medicines will be provided to participants in this study. The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study. Participants will need to visit the study doctor 3 times in total during the study. During these visits, study data will be collected by the study doctor.
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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All Participants
Male participants with severe or moderate hemophilia A who have been treated with FVIII concentrate octocog alfa (Advate) during at least 12 months prior to the study enrollment, who started octocog alfa treatment in 2021 or currently being treated with octocog alfa will be observed in this study.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* had been on standard prophylaxis or PK-tailored prophylaxis with octocog alfa during at least 12 months prior to the study enrollment (150 participants) or who started Advate® treatment in 2021 (20 participants),
* is being treated with octocog alfa at the moment of enrolment with any of the above mentioned treatment modalities, and
* had been assigned octocog alfa provision in Federal reimbursement program 2021
* Availability of participants' records sufficient for data collection according to the study objectives during the retrospective period of the study for participants who had been on standard prophylaxis or PK-tailored prophylaxis with octocog alfa during at least 12 months prior to the study enrollment
* Written informed consent provided by the participant or, in case of children below 14 years of age, by participant's parent or participant's legally acceptable representative.
Exclusion Criteria
* Participation in any interventional study of products for hemophilia or other hemostasis disturbances treatment during 12 months prior to the study enrollment for participants who has retrospective data collection period and during 12 months after the study enrollment for all participants.
MALE
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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City Children's Hospital No. 1
Kazan', Tatarstan Republic, Russia
Chelyabinsk Regional Children's Clinical Hospital
Chelyabinsk, , Russia
Children's Regional Clinical Hospital
Khabarovsk, , Russia
Krasnoyarsk Regional Clinical Center for Maternal and Child Health
Krasnoyarsk, , Russia
Morozovskaya Children's City Clinical Hospital of the Department of Healthcare of the city of Moscow
Moscow, , Russia
State Budgetary Institution of Healthcare "Republican children's clinical hospital" of the Ministry of Health of the Kabardino-Balkar Republic
Nal'chik, , Russia
State Novosibirsk Regional Clinical Hospital
Novosibirsk, , Russia
Regional Children's Clinical Hospital
Rostov-on-Don, , Russia
City Polyclinic No. 37
Saint Petersburg, , Russia
Regional Children's Clinical Hospital No. 1
Vladivostok, , Russia
Volgograd Regional Clinical Oncological Dispensary
Volgograd, , Russia
Voronezh Regional Children's Clinical Hospital No. 1
Voronezh, , Russia
State Autonomous Healthcare Institution of the Sverdlovsk Region "Regional Children's Clinical Hospital"
Yekaterinburg, , Russia
Countries
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Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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MACS-2020-051901
Identifier Type: OTHER
Identifier Source: secondary_id
TAK-761-4001
Identifier Type: -
Identifier Source: org_study_id
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