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Study of AAV5-hFIX in Severe or Moderately Severe Haemophilia B

NCT05360706 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 9

Last updated 2025-08-26

No results posted yet for this study

Summary

This is an open-label, extension study enrolling patients who have successfully completed all assessments in Study CT-AMT-060-01 (Years 1-5). Assessment phase will begin at Visit 36 (the first clinical visit in this extension study, approximately 5.5 years after the initial dosing visit Study CT-AMT-060-01) and go to Visit 45 (10-years post-dosing in Study CT-AMT-060-01).

Conditions

  • Hemophilia B

Interventions

GENETIC

AAV5-hFIX

AAV5 containing a codon-optimized human factor IX gene

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
2021-03-18
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Drug
Yes

Countries

  • Germany
  • Netherlands

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 NCT05360706 on ClinicalTrials.gov