AN OPEN-LABEL, NON-INVESTIGATIONAL PRODUCT, LEAD-IN STUDY TO EVALUATE AT LEAST 6 MONTHS OF PROSPECTIVE EFFICACY AND SAFETY DATA OF FACTOR IX OR FACTOR VIII PROPHYLAXIS REPLACEMENT THERAPY IN THE USUAL CARE SETTING OF MODERATELY SEVERE TO SEVERE ADULT HEMOPHILIA B SUBJECTS (FIX:C=2%) WHO ARE NEGATIVE FOR nAB TO AAV VECTOR-SPARK100 AND MODERATELY SEVERE TO SEVERE HEMOPHILIA A ADULT SUBJECTS (FVIII:C=1%) WHO ARE NEGATIVE FOR nAB TO AAV VECTOR SB-525 CAPSID (AAV6), PRIOR TO THE RESPECTIVE THERAPEUTIC PH 3 GENE THERAPY STUDIES (NCT03587116)
Benegene
This trial is Currently recruiting
Registration number NCT03587116
Program & service
This trial is being run with the Cancer service, and as part of the Haematology program.
Trial phase
Phase 3
Trial participation type
This trial has been designed for the Clinical Research of a Drug.
Principal investigator
Professor Huyen Tran
More information
To find out more about this clinical trial, please review full details on the ANZCTR website.
View on ANZCTRIf you would like further details or have any questions about this clinical trial, we encourage you to get in touch with us and a member of our team will be happy to provide you with more information.