Trial Profile
AN OPEN-LABEL, NON-INVESTIGATIONAL PRODUCT, MULTI-CENTER, LEAD-IN STUDY TO EVALUATE 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 NEUTRALIZING 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 (See Detailed Description Section for Official Protocol Title)
Status:
Active, no longer recruiting
Phase of Trial:
Phase III
Latest Information Update: 13 Sep 2023
Price :
$35
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At a glance
- Drugs Factor IX replacements (Primary) ; Factor VIII replacements (Primary) ; Fidanacogene-elaparvovec (Primary) ; Giroctocogene fitelparvovec (Primary)
- Indications Haemophilia A; Haemophilia B
- Focus Adverse reactions; Therapeutic Use
- Acronyms BENEGENE-1
- Sponsors Pfizer
- 19 Jun 2023 This trial has been completed in Sweden.
- 05 Jun 2023 Status changed from recruiting to active, no longer recruiting.
- 17 May 2023 Planned End Date changed from 29 Mar 2024 to 18 Feb 2024.