Status:
ACTIVE_NOT_RECRUITING
Long-Term Safety and Efficacy of Spark-Sponsored Gene Therapies in Males With Hemophilia A
Lead Sponsor:
Spark Therapeutics, Inc.
Conditions:
Hemophilia A
Eligibility:
MALE
18+ years
Brief 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...
Detailed Description
This study will follow patients with hemophilia A, who have received a single intravenous administration of SPK-8011 or SPK-8016 in any prior Spark-sponsored SPK-8011 or SPK-8016 study. Participants w...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Have received a single intravenous administration of SPK-8011 or SPK-8016 in either Study SPK-8011-101 or SPK-8016-101, respectively.
- Understand the purpose and risks of the study and provide signed and dated informed consent before undergoing any study-specific procedures.
- Exclusion Criteria
- Participants are excluded from the study if any of the following criteria apply:
- Unable or unwilling to comply with the schedule of visits and study assessments as described in this study protocol.
Exclusion
Key Trial Info
Start Date :
August 14 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2032
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT03432520
Start Date
August 14 2018
End Date
December 1 2032
Last Update
November 29 2024
Active Locations (12)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
2
Mississippi Center for Advanced Medicine
Madison, Mississippi, United States, 39110
3
Truman Medical Centers
Kansas City, Missouri, United States, 64108
4
Oregon Health & Science University
Portland, Oregon, United States, 97239