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Long-Term Safety and Efficacy of Spark-Sponsored Gene Therapies in Males With Hemophilia A
Sponsor: Spark Therapeutics, Inc.
Summary
This long-term follow-up study will continue to evaluate the long-term safety and efficacy of SPK-8011 and SPK-8016 in males with hemophilia A, who have received a single intravenous administration of SPK-8011 or SPK-8016 in any Spark-sponsored SPK-8011 or SPK-8016 study.
Official title: A Multi-Center Evaluation of the Long-Term Safety and Efficacy of Spark-sponsored Gene Therapies in Males With Hemophilia A
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
29
Start Date
2018-08-14
Completion Date
2032-12
Last Updated
2024-11-29
Healthy Volunteers
No
Conditions
Interventions
SPK-8011
Observational long-term safety follow-up study of participants previously treated with SPK-8011 in any Spark-sponsored SPK-8011 study
SPK-8016
Observational long-term safety follow-up study of participants previously treated with SPK-8016 in any Spark-sponsored SPK-8016 study
Locations (12)
Boston Children's Hospital
Boston, Massachusetts, United States
Mississippi Center for Advanced Medicine
Madison, Mississippi, United States
Truman Medical Centers
Kansas City, Missouri, United States
Oregon Health & Science University
Portland, Oregon, United States
Pennsylvania State University Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Hemophilia Center of Western Pennsylvania
Pittsburgh, Pennsylvania, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Royal Prince Alfred Hospital Department of Cell & Molecular Therapies
Sydney, New South Wales, Australia
The Alfred Hospital & Monash Medical Centre
Melbourne, Victoria, Australia
St. Michael's Hospital
Toronto, Ontario, Canada