An observational study in Hemophilia A, sponsored by Takeda. Completed at 8 sites in Korea, Republic of. Per ClinicalTrials.gov, last updated 2024-02-26.
Sponsored by Takeda · Observational
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.
866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.
This study's enrollment of 341 is above the median of 80 across 314 observational studies indexed under Hemophilia A.
Browse Hemophilia A studies →Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Hemophilia A participants in South Korea who will be newly prescribed with ADYNOVATE or already been prescribed with ADYNOVATE will be included in this study.
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:
Exclusion Criteria
Participants should be excluded from this study if:
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.
Biological: ADYNOVATE
Pegylated recombinant human factor VIII
Also known as: PEGylated rFVIII
Incidence of adverse events
Serious adverse events and non-serious adverse events
Time frame: Throughout the duration of patient participation of up to approximately 6 months
Frequency of adverse events
Serious adverse events and non-serious adverse events
Time frame: Throughout the duration of patient participation of up to approximately 6 months
Incidence of inhibitor titers for FVIII antibodies
By titer levels, high and lower titer categories
Time frame: Throughout the duration of patient participation of up to approximately 6 months
Number of treated bleeds
Number of treated bleeds throughout the study period
Time frame: Throughout the duration of patient participation of up to approximately 6 months
ADYNOVATE units required for bleed resolution
Number of ADYNOVATE units required for bleed resolution
Time frame: At bleed resolution, throughout the duration of patient participation of up to approximately 6 months
Number of ADYNOVATE infusions needed for the treatment of bleeding episodes
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
Time frame: At bleed resolution, throughout the duration of patient participation of up to approximately 6 months
Hemostatic effectiveness assessment of bleeding episodes treated with ADYNOVATE during prophylaxis treatment
Using a 4-point ordinal scale (Excellent, Good, Fair, or None)
Time frame: Throughout the duration of patient participation of up to approximately 6 months
Hemostatic effectiveness of ADYNOVATE for participants on an on-demand regimen
Using a 4-point ordinal scale (Excellent, Good, Fair, or None)
Time frame: At bleed resolution, throughout the duration of patient participation of up to approximately 6 months
Assessment of perioperative effectiveness of ADYNOVATE
Using a 4-point ordinal scale (Excellent, Good, Fair, or None)
Time frame: Throughout the duration of patient participation of up to approximately 6 months
Clinically significant changes in laboratory results
Number of clinically significant changes in laboratory results
Time frame: Throughout the duration of patient participation of up to approximately 6 months
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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