Hemophilia A
Conditions
Brief summary
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.
Interventions
BIOLOGICALADYNOVATE
Pegylated recombinant human factor VIII
Sponsors
Takeda Pharma Korea Co. Ltd.
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | Throughout the duration of patient participation of up to approximately 6 months | Serious adverse events and non-serious adverse events |
| Frequency of adverse events | Throughout the duration of patient participation of up to approximately 6 months | Serious adverse events and non-serious adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ADYNOVATE units required for bleed resolution | At bleed resolution, throughout the duration of patient participation of up to approximately 6 months | Number of ADYNOVATE units required for bleed resolution |
| Number of ADYNOVATE infusions needed for the treatment of bleeding episodes | At bleed resolution, throughout the duration of patient participation of up to approximately 6 months | The number of ADYNOVATE infusions needed for each bleeding episode is determined by the participant, his/her caregiver, and/or clinician treating the participant, and is based upon the participant's response to treatment |
| Hemostatic effectiveness assessment of bleeding episodes treated with ADYNOVATE during prophylaxis treatment | Throughout the duration of patient participation of up to approximately 6 months | Using a 4-point ordinal scale (Excellent, Good, Fair, or None) |
| Incidence of inhibitor titers for FVIII antibodies | Throughout the duration of patient participation of up to approximately 6 months | By titer levels, high and lower titer categories |
| Assessment of perioperative effectiveness of ADYNOVATE | Throughout the duration of patient participation of up to approximately 6 months | Using a 4-point ordinal scale (Excellent, Good, Fair, or None) |
| Clinically significant changes in laboratory results | Throughout the duration of patient participation of up to approximately 6 months | Number of clinically significant changes in laboratory results |
| Hemostatic effectiveness of ADYNOVATE for participants on an on-demand regimen | At bleed resolution, throughout the duration of patient participation of up to approximately 6 months | Using a 4-point ordinal scale (Excellent, Good, Fair, or None) |
| Number of treated bleeds | Throughout the duration of patient participation of up to approximately 6 months | Number of treated bleeds throughout the study period |
Countries
South Korea
Outcome results
None listed