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

CSL Behring9 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hemophilia B

Interventions

AAV5-hFIXGENETIC

AAV5 containing a codon-optimized human factor IX gene

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

Vivantes Klinikum im Friedrichshain

Berlin, Germany

Universitaetsklinikum Frankfurt - Klinikum der Johann Wolfgang Goethe Universitae

Frankfurt, Germany

Amsterdam UMC - Locatie AMC

Amsterdam, Netherlands

Groningen UMC

Groningen, Netherlands