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

CSL Behring logo

CSL Behring

Status

Active, not recruiting

Conditions

Hemophilia B

Treatments

Genetic: AAV5-hFIX

Study type

Observational

Funder types

Industry

Identifiers

NCT05360706
2020-000739-28 (EudraCT Number)
CSL220_1002 (CT-AMT-060-04)

Details and patient eligibility

About

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).

Enrollment

9 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects with congenital hemophilia B who completed Study CTAMT-060-01
  • Able to provide informed consent following receipt of verbal and written information about the trial.

Exclusion criteria

Enrolled subjects will have already been assessed based on the exclusion criteria for Study CT-AMT-060-01.

Trial design

9 participants in 1 patient group

CSL220
Description:
AAV5 containing a codon-optimized human factor IX gene
Treatment:
Genetic: AAV5-hFIX

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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