Long-Term Safety and Efficacy of SPK-8011 in Males With Hemophilia A



Status:Enrolling by invitation
Conditions:Anemia, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:12/19/2018
Start Date:August 14, 2018
End Date:December 2022

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A Multi-Center Evaluation of the Long-Term Safety and Efficacy of SPK-8011 [Adeno-Associated Viral Vector With B-Domain Deleted Human Factor VIII Gene] in Males With Hemophilia A

This long-term follow-up study will continue to evaluate the long-term safety and efficacy of
SPK-8011 in males with hemophilia A, who have received a single intravenous administration of
SPK-8011 in any Spark-sponsored SPK-8011 study.

This study will follow patients with hemophilia A, who have received a single intravenous
administration of SPK-8011 in any prior Spark-sponsored SPK-8011 study. Subjects will be
followed for up to a total of 5 years post infusion (including the time on the dosing study).

Inclusion Criteria:

1. Males with hemophilia A, who have received a single intravenous administration of
SPK-8011 in any Spark sponsored SPK-8011 study

2. Individuals who understand the purpose and the risks of the study, and who provide
signed and dated informed consent before undergoing any study-specific procedures.

Exclusion Criteria:

1. Individuals who are unable or unwilling to comply with the schedule of visits and study
assessments as described in this study protocol.
We found this trial at
2
sites
Pittsburgh, Pennsylvania 15213
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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