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 ANZCTR

If 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.