NCT05962398Enrolling by invitationPhase 2/3
Long-term Follow-up Study of Male Adults With Hemophilia B Previously Treated With Etranacogene Dezaparvovec (CSL222)
An Extension Study Assessing the Long-term Safety and Efficacy of Etranacogene Dezaparvovec (CSL222) Previously Administered to Adult Male Subjects With Hemophilia B
Source: ClinicalTrials.gov · Last updated 18 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The primary purpose of this study is to assess the long-term safety and efficacy in male adults with hemophilia B who were treated with CSL222 (CSL222) in parent studies CSL222\_2001 (NCT03489291) or CSL222\_3001 (NCT03569891).
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 2/3
- Study type
- Observational
- Enrollment
- 56 (estimated)
- First submitted
- 18 Jul 2023
- Start date
- 30 Aug 2023
- Primary completion date
- 23 Mar 2035
- Lead sponsor
- CSL Behring
- Diseases
- Haemophilia
- NCT number
- NCT05962398
- EU CT number
- 2023-503765-37-00
What you commit to
- Study type: Observational · Phase 2/3
- Planned participants: 56
- From 30 Aug 2023 to the primary completion date, 23 Mar 2035
- 28 sites in 8 countries
- 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.
Other
- Not Applicable
Who the study is looking for
- Received treatment with CSL222 in Study CSL222\_2001 or Study CSL222\_3001, and completed participation in Study CSL222\_2001 or Study CSL222\_3001 or at least 5 years have passed since receiving CSL222.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (28)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Active, not recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Active, not recruiting |
| Vivantes Netzwerk fuer Gesundheit GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Active, not recruiting |
| 18-54 Addenbrooke's Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| 18-52 Barts Health NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| 18-53 University Hospital Southampton NHS Foundation Trust Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| St James's Hospital Coordinator of this site? Confirm its status | Dublin 8 | Ireland | Active, not recruiting |
| Academisch Medisch Centrum Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Active, not recruiting |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Active, not recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Active, not recruiting |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Active, not recruiting |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Malmo | Sweden | Active, not recruiting |
| 10-10 University of Michigan Medical Center Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| 10-25 University of Colorado Denver Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| 10-16 University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| 10-28 University of Texas Health Science Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| 10-14 Arkansas Children's Hospital - Pharmacology Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| 10-22 Orthopaedic Institute for Children Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| 10-21 Children's Hospital of Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| 10-20 Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| 10-15 Phoenix Childrens Hospital Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| 10-18 Oregon Health & Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| 10-63 UC Davis Medical Center Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| 10-26 University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| 10-12 University of California, San Diego (UCSD) Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| 10-62 Washington Institute for Coagulation Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| 10-19 University of South Florida Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.