Long-term Follow-up of Adult Men Treated for Hemophilia B With Gene Therapy
Follows adult men with hemophilia B who previously received etranacogene dezaparvovec gene therapy.
Plain-language title generated from the registry record
Registry title: Long-term Follow-up Study of Male Adults With Hemophilia B Previously Treated With Etranacogene Dezaparvovec (CSL222)
Key facts
- Where
- Copenhagen Oe, DenmarkSee the site
- Phase
- Phase 2/3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with hemophilia B who already received CSL222 in an earlier study. It follows them over the long term to check safety and effect.
- Age
- 18 years and older
- Sex
- Men only
- Earlier treatment
- Must have received CSL222 in study CSL222_2001 or CSL222_3001. Must have finished that study, or at least 5 years have passed since receiving CSL222.
Read by machine on 12 November 2026.
Where in Denmark
- RigshospitaletCopenhagen Oe, DenmarkNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- CSL Behring
- Trial code
- NCT05962398EU 2023-503765-37-00
- Record updated
- 18 July 2025
- Original description
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).Read full original descriptionShow less
An Extension Study Assessing the Long-term Safety and Efficacy of Etranacogene Dezaparvovec (CSL222) Previously Administered to Adult Male Subjects With Hemophilia B
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).
Inclusion: 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.
Exclusion: Not Applicable.