An AllTrials project

NCT03587116: An ongoing trial by Pfizer

This trial is ongoing. It must report results 2 years, 8 months from now.

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 Ongoing
ACT or pACT? This is what FDAAA officially calls an "Applicable Clinical Trial"
Start date July 26, 2018
Completion date July 13, 2022
Required reporting date July 13, 2023, midnight
Actual reporting date None
Date last checked at ClinicalTrials.gov Oct. 19, 2020
Days late None