NCT03824522Completed
Post Marketing Surveillance Study for ADYNOVATE in South Korea
Source: ClinicalTrials.gov · Last updated 26 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 341 (actual)
- First submitted
- 29 Jan 2019
- Start date
- 25 Feb 2019
- Primary completion date
- 5 Jan 2024
- Lead sponsor
- Takeda
- Diseases
- Haemophilia
- NCT number
- NCT03824522
What you commit to
- Study type: Observational
- Participants enrolled: 341
- From 25 Feb 2019 to the primary completion date, 5 Jan 2024
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participant is enrolled in an interventional trial using an investigational product other than ADYNOVATE.
Other
- 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.
Who the study is looking for
- 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).
Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kyungpook National University Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Daegu Catholic University Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Kyungpook National University Chilgok Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Korea Hemophilia Foundation (Seoul) Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Kyung Hee University Hospital at Gangdong Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Kim Hugh Chul Internal Medicine Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ulsan University Hospital Coordinator of this site? Confirm its status | Ulsan | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.