This is an open-label extension study that continues to follow patients who successfully completed all assessments in study CT-AMT-060-01. The assessment phase begins at Visit 36, the first clinical visit roughly 5.5 years after the initial AAV5-hFIX (CSL220) dosing visit, and continues to Visit 45, which is 10 years post-dosing. Only people with congenital hemophilia B who completed CT-AMT-060-01 and could provide informed consent after verbal and written information about the trial were enrolled.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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.