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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

Trial Profile

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

Recruiting
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
  • Most Recent Events

    • 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
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