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 |
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.
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).
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.
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