Hemophilia ANCT03824522
Post Marketing Surveillance Study for ADYNOVATE in South Korea
An observational study of Hemophilia A, run by Takeda at 8 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemophilia A
- What is being tested?
- ADYNOVATE
- How many people
- 341 participants
- Where
- 8 sitesSouth Korea
- Study dates
- 25 Feb 2019to 5 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites
Kyungpook National University Chilgok Hospital
Daegu, 41404
Kyungpook National University Hospital
Daegu, 41944
Daegu Catholic University Medical Center
Daegu, 42472
Severance Hospital Yonsei University Health System
Seoul, 03722
Kyung Hee University Hospital at Gangdong
Seoul, 05278
Kim Hugh Chul Internal Medicine
Seoul, 05538
Korea Hemophilia Foundation (Seoul)
Seoul, 06641
Ulsan University Hospital
Ulsan, 44033
About this study
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.
- Conditions
- Hemophilia A
- Being tested
- ADYNOVATE
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADYNOVATEBiological
Also called PEGylated rFVIII
Pegylated recombinant human factor VIII
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: ADYNOVATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Serious adverse events and non-serious adverse events
Measured: Throughout the duration of patient participation of up to approximately 6 months
Frequency of adverse events
Serious adverse events and non-serious adverse events
Measured: Throughout the duration of patient participation of up to approximately 6 months
Secondary outcomes (8)
Incidence of inhibitor titers for FVIII antibodies
By titer levels, high and lower titer categories
Measured: Throughout the duration of patient participation of up to approximately 6 months
Number of treated bleeds
Number of treated bleeds throughout the study period
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Throughout the duration of patient participation of up to approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start25 Feb 2019
- Primary completion5 Jan 2024
- Study completion5 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Takeda Pharma Korea Co. Ltd.
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824522
- Sponsor's protocol ID
- 261603
- Status last verified
- Feb 2024
- First submitted
- 29 Jan 2019
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Kim JY, Hwang T, Park SK, Yoo KY, Choi EJ, Kim S, You CW, Kim E, Jung A, Park YS. Real-world safety and effectiveness of rurioctocog alfa pegol in 338 patients with hemophilia A in South Korea: A postmarketing surveillance study. Thromb Res. 2025 Sep;253:109402. doi: 10.1016/j.thromres.2025.109402. Epub 2025 Jul 9.
PubMed 40680470
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance Study for ADYNOVATE in South Korea
- ClinicalTrials.gov ID
- NCT03824522
- Acronym / sponsor ID
- 261603
- Conditions
- Hemophilia A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Collaborators
- Takeda Pharma Korea Co. Ltd.
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 5 Jan 2024 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Study Participants | – | Biological: ADYNOVATEParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADYNOVATEAlso: PEGylated rFVIIIPegylated recombinant human factor VIII | Biological | All Study Participants |
Primary outcome
Incidence of adverse events
Time frame: Throughout the duration of patient participation of up to approximately 6 months
Serious adverse events and non-serious adverse events
Frequency of adverse events
Time frame: Throughout the duration of patient participation of up to approximately 6 months
Serious adverse events and non-serious adverse events
8 secondary outcomes
Incidence of inhibitor titers for FVIII antibodies
Time frame: Throughout the duration of patient participation of up to approximately 6 months
Number of treated bleeds
Time frame: Throughout the duration of patient participation of up to approximately 6 months
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
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
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
Time frame: At bleed resolution, throughout the duration of patient participation of up to approximately 6 months
Assessment of perioperative effectiveness of ADYNOVATE
Time frame: Throughout the duration of patient participation of up to approximately 6 months
Clinically significant changes in laboratory results
Time frame: Throughout the duration of patient participation of up to approximately 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Derived from this study: PubMed 40680470Kim JY, Hwang T, Park SK, Yoo KY, Choi EJ, Kim S, You CW, Kim E, Jung A, Park YS. Real-world safety and effectiveness of rurioctocog alfa pegol in 338 patients with hemophilia A in South Korea: A postmarketing surveillance study. Thromb Res. 2025 Sep;253:109402. doi: 10.1016/j.thromres.2025.109402. Epub 2025 Jul 9.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
Related trials for Hemophilia A
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
RecruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
Hemophilia A
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A, run by Takeda at 8 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Throughout the duration of patient participation of up to approximately 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03824522, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.