A Phase 3, Single-arm, Open-label, Multicenter Study of the Safety and Efficacy of Dirloctocogene Samoparvovec (SPK 8011, Adeno-associated Viral Vector With B-domain Deleted Human Factor VIII Gene) in Adults With Severe or Moderately Severe Hemophilia A

Status: Withdrawn prior to enrolment

Phase of Trial: Phase III

Latest Information Update: 17 Dec 2024

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At a glance

Drugs Dirloctocogene samoparvovec (Primary)
Indications Haemophilia A
Focus Therapeutic Use
Acronyms KEYSTONE 1
Sponsors Spark Therapeutics

Most Recent Events

13 Dec 2024 Status changed from not yet recruiting to withdrawn prior to enrolment.
15 Apr 2024 Planned number of patients changed from 80 to 85.
12 Mar 2024 New trial record

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