NCT03587116: A reported trial by Pfizer
This trial has reported on time, in line with the regulations.
Full data
| Full entry on ClinicalTrials.gov | NCT03587116 |
|---|---|
| Title | 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 (See Detailed Description Section for Official Protocol Title) |
| Results Status | Reported |
| ACT or pACT? | This is what FDAAA officially calls an "Applicable Clinical Trial" |
| Start date | July 26, 2018 |
| Completion date | Dec. 13, 2024 |
| Required reporting date | Dec. 13, 2025, midnight |
| Actual reporting date | Oct. 23, 2025 |
| Date last checked at ClinicalTrials.gov | Dec. 12, 2025 |
| Days late | None |