🏛️ Verified NIH Record • Updated 2026-02-13
A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A (NCT04158934)
Evaluation of Long-term Safety of ADYNOVI/ADYNOVATE (Antihaemophilic Factor [Recombinant] PEGylated, Rurioctocog Alfa Pegol) in Patients With Haemophilia A - An ADYNOVI/ADYNOVATE Post-Authorisation Safety Study (PASS)
🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Baxalta now part of Shire
🩺 Plain-English Summary (8th-Grade Level)
The main aim of this study is to check for long-term side effects from ADYNOVI/ADYNOVATE prophylaxis in participants with haemophilia A when used under standard clinical practice in the real-world clinical setting.
Who can join: Review the eligibility criteria below.
Location: UF Health Shands Hospital — Gainesville, Florida
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (36 Sites)
Showing the first 25 of 36 sites.
- UF Health Shands Hospital — Gainesville, Florida
- SHAT of Oncohaematology Diseases — Sofia,
- Clinical Hospital Sveti Duh — Zagreb,
- University hospital centre Zagreb — Zagreb,
- University hospital centre Zagreb — Zagreb,
- Fakultni nemocnice v Motole — Prague,
- Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z. — Ústí nad Labem,
- SRH Kurpfalzkrankenhaus Heidelberg GmbH — Heidelberg, Baden-Wurttemberg
- Vivantes Klinikum im Friedrichshain — Berlin,
- Universitaetsklinikum Bonn AoeR — Bonn,
- Werlhof-Institut GmbH — Hanover,
- Heim Pal Orszagos Gyermekgyogyaszati Intezet — Budapest,
- Eszak-Pesti Centrumkorhaz - Honvedkorhaz — Budapest,
- Debreceni Egyetem — Debrecen,
- Mohacsi Korhaz — Mohács,
- Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz — Nyíregyháza,
- Pecsi Tudomanyegyetem Klinikai Kozpont — Pécs,
- Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico — Milan,
- Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza — Roma,
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma,
- University Medical Centre Groningen-UMCG — Groningen,
- Kyung Hee University Hospital at Gangdong — Seoul,
- Ulsan University Hospital — Ulsan,
- Hospital Universitari Son Espases — Palma de Mallorca, Balearic Islands
- Hospital Universitari Vall d'Hebron — Barcelona,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Hemophilia A
- Study to Test the Safety and How Well Patients With Severe Hemophilia A Respond to Treatment With BAY 2599023 (DTX 201), a Drug Therapy That Delivers a Healthy Version of the Defective Factor VIII Gene Into the Nucleus of Liver Cells Using an Altered, Non-infectious Virus (AAV) as a "Shuttle" — Little Rock, Arkansas
- Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A — Los Angeles, California
- Gene Therapy Trial for Platelet Derived Factor VIII Production in Hemophilia A — Milwaukee, Wisconsin
- A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A — Gilbert, Arizona
- Study to Evaluate the Efficacy and Safety of PF-07055480 / Giroctocogene Fitelparvovec Gene Therapy in Moderately Severe to Severe Hemophilia A Adults — Mountain View, California
Explore by condition: All Hemophilia A clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.