A Study in Children, Teenagers and Adults With Severe Hemophilia A Who Switched From Other Factor VIII Treatments to Adynovate

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

153 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-30

Study Completion Date

2022-02-28

Brief Summary

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The main aims of the study are to assess the safety profile of Adynovate as well as how well people respond to the preventive treatment with Adynovate.

This study is about reviewing and collecting data of the participants before and after the switch to Adynovate that are already available. No new information will be collected during this study. The total time for data collection in the study will be approximately 72 months (36 months before and 36 months after switching to Adynovate). Participants will not receive Adynovate as part of this study.

As participants are not treated in this study, they do not need to visit their doctor in addition to their normal visits.

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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

RETROSPECTIVE

Study Groups

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All Participants

All participants diagnosed with severe hemophilia A previous received prophylaxis regimen for Standard Half-life/Extended Half-life Factor VIII (SHL/EHL-FVIII) products will be compared to after the participants switched to regular prophylaxis with Adynovate with at least 6 months follow up.

Non-Interventional

Intervention Type OTHER

This is a Non-Interventional Study.

Interventions

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Non-Interventional

This is a Non-Interventional Study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Participants with severe hemophilia A.
* All age groups (less than \[\<\] 12 and greater than \[\>\] 12 years of age).
* Participant with greater than equal to (\>=) 150 documented exposure days (EDs).
* Treated with Adynovate:

* Having a PK analysis done/data available for post-hoc modeling
* Having recorded clinical outcomes analysis: for \> 6 months
* Treated with a SHL/EHL-FVIII product for at least six months before switching to Adynovate
* To qualify for the secondary objective participants will need to have a WAPPS study performed on Adynovate and on the SHL/EHL-FVIII they were treated before switching.

Exclusion Criteria

* Any participant who meets any of the following criteria will not qualify for entry into the study:
* Participants with only on-demand Factor VIII (FVIII) use.
* Current presence of FVIII inhibitory antibodies. (Participants with a history of inhibitors, if any, will be considered for a sensitivity analysis).
* Diagnosis of other inherited or acquired hemostatic defect other than hemophilia A.

Eligible Sex

ALL

Accepts Healthy Volunteers

No