Post Marketing Surveillance Study for ADYNOVATE in South Korea

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

341 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-25

Study Completion Date

2024-01-05

Brief Summary

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The main aim of this study is to check for side effects and medical problems in participants with hemophilia A who are receiving ADYNOVATE in routine clinical practice. Also, it will be checked how effective ADYNOVATE is at stopping a bleed, at preventing bleeding episodes when used routinely for prevention and at controlling hemophilia-related bleeding during surgeries.

Participants with hemophilia A who will be newly prescribed with ADYNOVATE treatment or have already been taking ADYNOVATE treatment according to the physician's decision will be included in this study.

Participants will visit the study clinic as a part of their routine clinical practice and will be contacted by phone calls/home visits by home care workers for collection of treatment related data during the 6-month observation period.

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Detailed Description

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Conditions

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Hemophilia A

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All Study Participants

Participants who are newly prescribed with Adynovate and participants previously treated with Adynovate will be treated with ADYNOVATE for hemophilia A at the time of enrollment according to a regimen determined by the study site treating physician.

ADYNOVATE

Intervention Type BIOLOGICAL

Pegylated recombinant human factor VIII

Interventions

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ADYNOVATE

Pegylated recombinant human factor VIII

Intervention Type BIOLOGICAL

Other Intervention Names

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PEGylated rFVIII

Eligibility Criteria

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Inclusion Criteria

Participants with a diagnosis of hemophilia A who will be newly prescribed with ADYNOVATE or already have been prescribed ADYNOVATE according to the study physician's judgment shall be included in this study if:

* The participant or legally authorized representative has given written informed consent to participate in the study.
* The participant is indicated for treatment according to the ADYNOVATE South Korea prescribing information (PI).

Exclusion Criteria

Participants should be excluded from this study if:

* The participant or legally authorized representative does not wish to participate in the study.
* Any of the contraindications included in the PI for ADYNOVATE apply.
* Participant is enrolled in an interventional trial using an investigational product other than ADYNOVATE.

Eligible Sex

ALL

Accepts Healthy Volunteers

No