Trials / Enrolling By Invitation
Enrolling By InvitationNCT05962398
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
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 56 (estimated)
- Sponsor
- CSL Behring · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | AAV5-hFIXco-Padua | Single intravenous infusion of AAV5-hFIXco-Padua in the study CSL222\_2001 (NCT03489291) or CSL222\_3001 (NCT03569891). |
Timeline
- Start date
- 2023-08-30
- Primary completion
- 2035-03-23
- Completion
- 2035-03-23
- First posted
- 2023-07-27
- Last updated
- 2025-07-18
Locations
28 sites across 8 countries: United States, Belgium, Denmark, Germany, Ireland, Netherlands, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05962398. Inclusion in this directory is not an endorsement.