AN OPEN-LABEL, NON-INVESTIGATIONAL PRODUCT, MULTI-CENTER, LEAD-IN STUDY TO EVALUATE AT LEAST 6 MONTHS OF PROSPECTIVE EFFICACY AND SELECTED SAFETY DATA OF FACTOR IX (FIX) 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 ANTIBODIES (NAB) TO ADENO-ASSOCIATED VIRUS VECTOR (AAV)-SPARK100
Phase of Trial: Phase III
Latest Information Update: 16 Feb 2019
At a glance
- Drugs Factor IX replacements (Primary) ; Fidanacogene-elaparvovec (Primary)
- Indications Haemophilia B
- Focus Adverse reactions; Therapeutic Use
- Sponsors Pfizer
- 04 Jan 2019 Planned End Date changed from 16 Nov 2020 to 11 Dec 2020.
- 04 Jan 2019 Planned primary completion date changed from 16 Nov 2020 to 11 Dec 2020.
- 02 Jul 2018 New trial record