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NCT03824522
Post Marketing Surveillance Study for ADYNOVATE in South Korea
trial testing ADYNOVATE in Hemophilia A in 341 participants. Completed in 5 January 2024.
5 January 2024
Quick facts
| Lead sponsor | Takeda |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 341 |
| Start date | 25 February 2019 |
| Primary completion | 5 January 2024 |
| Estimated completion | 5 January 2024 |
| Sites | 8 locations across South Korea |
Drugs / interventions tested
- ADYNOVATE — full drug profile →
Conditions studied
- Hemophilia A — all drugs for Hemophilia A →
Sponsor
Takeda — full company profile →
Who can join
Eligibility, any sex, with Hemophilia A. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Real-world safety and effectiveness of rurioctocog alfa pegol in 338 patients with hemophilia A in South Korea: A postmarketing surveillance study.
Kim JY, Hwang T, Park SK, Yoo KY, et al · · 2025 · PMID 40680470 · DOI 10.1016/j.thromres.2025.109402
Verify or expand the search:
- PubMed search for NCT03824522
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ADYNOVATE
Trials testing the same drug.
- NCT03169972 — ADYNOVATE Drug Use-Results Survey · completed
Other recruiting trials for Hemophilia A
Currently open trials in the same condition.
- NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
- NCT07416604 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A · Phase 3 · recruiting
- NCT07523399 — Joint Health, Balance and Quality of Life in Adults With Hemophilia A · recruiting
- NCT06833983 — To Evaluate the Clinical Study of GS1191-0445 Injection in the Treatment of Hemophilia A · Phase 3 · recruiting
- NCT06579144 — Pharmacokinetic Comparison of Efanesoctocog Alfa vs Other EHL-rFVIII Products in Participants With Severe Haemophilia A · Phase 1 · recruiting
Other Takeda trials
Trials by the same sponsor.
- NCT05669729 — A Survey to Assess Participants', Caregivers', and Nurses' Use and Understanding of Educational Material on Velagluceras · not yet recruiting
- NCT07403968 — A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease · Phase 2 · not yet recruiting
- NCT07293364 — A Study to Learn About the C1-Inhibitor Function as Diagnosis for Hereditary Angioedema · NA · not yet recruiting
- NCT07218393 — A Study About the Diagnosis and Management of Hereditary Angioedema (HAE) in Egypt · not yet recruiting
- NCT07445087 — A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03824522 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Takeda
- Last refreshed: 26 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03824522.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing