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Long-term Follow-up Study of Male Adults With Hemophilia B Previously Treated With Etranacogene Dezaparvovec (CSL222)

NCT05962398 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 56

Last updated 2025-07-18

No results posted yet for this study

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

  • Hemophilia B

Interventions

GENETIC

AAV5-hFIXco-Padua

Single intravenous infusion of AAV5-hFIXco-Padua in the study CSL222\_2001 (NCT03489291) or CSL222\_3001 (NCT03569891).

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Study Director · CSL Behring

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-30
Primary Completion
2035-03-23
Completion
2035-03-23
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Denmark
  • Germany
  • Ireland
  • Netherlands
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05962398 on ClinicalTrials.gov