NCT03587116: An ongoing trial by Pfizer
This trial is ongoing. It must report results 11 months from now.
Full data
Full entry on ClinicalTrials.gov | NCT03587116 |
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Title | 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) |
Results Status | Ongoing |
ACT or pACT? | This is what FDAAA officially calls an "Applicable Clinical Trial" |
Start date | July 26, 2018 |
Completion date | Feb. 18, 2024 |
Required reporting date | Feb. 17, 2025, midnight |
Actual reporting date | None |
Date last checked at ClinicalTrials.gov | Feb. 9, 2024 |
Days late | None |