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Study of a Gene Therapy Treatment for Hemophilia A — KEYSTONE 1  

Hemophilia A Clinical Trial

Official title:
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

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of SPK-8011 in preventing bleed episodes compared with FVIII prophylaxis in participants with hemophilia A without FVIII inhibitors on routine FVIII prophylaxis.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06297486
Study type Interventional
Source Spark Therapeutics, Inc.
Contact Clinical Trial Director
Phone Spark Therapeutics, Inc.
Email clinicaltrials@sparktx.com
Status Recruiting
Phase Phase 3
Start date March 13, 2024
Completion date September 4, 2035
View Details
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