Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Long-Term Safety and Efficacy of Spark-Sponsored Gene Therapies in Males With Hemophilia A
NCT03432520 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- GENETIC SPK-8011
- GENETIC SPK-8016
Study Locations (12)
Pennsylvania
- Pennsylvania State University Milton S. Hershey Medical Center — Hershey
- The Children's Hospital of Philadelphia — Philadelphia
- Thomas Jefferson University — Philadelphia
- Hemophilia Center of Western Pennsylvania — Pittsburgh
Massachusetts
- Boston Children's Hospital — Boston
Mississippi
- Mississippi Center for Advanced Medicine — Madison
Missouri
- Truman Medical Centers — Kansas City
Oregon
- Oregon Health & Science University — Portland
Virginia
- Virginia Commonwealth University — Richmond
New South Wales
- Royal Prince Alfred Hospital Department of Cell & Molecular Therapies — Sydney
Victoria
- The Alfred Hospital & Monash Medical Centre — Melbourne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2018-08-14 |
| Est. Completion | 2032-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03432520
The ClinicalTrials.gov registry entry for NCT03432520 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Spark Therapeutics, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Hemophilia A appearing as the primary indexed condition, and to 2 interventions — of which SPK-8011 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03432520 reports 12 study locations spanning 9 distinct geographic areas — top geographies include Pennsylvania, Massachusetts, Mississippi. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03432520 about?
NCT03432520 is a clinical study titled "Long-Term Safety and Efficacy of Spark-Sponsored Gene Therapies in Males With Hemophilia A". 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.
What is the current status of trial NCT03432520?
This trial is currently active not recruiting. The enrollment target is 29 participants. The study started on 2018-08-14. Estimated completion is 2032-12.
What conditions does trial NCT03432520 study?
This clinical trial studies the following conditions: Hemophilia A. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03432520?
The interventions under investigation include: SPK-8011 (GENETIC), SPK-8016 (GENETIC). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03432520?
This trial is sponsored by Spark Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03432520 being conducted?
This trial has 12 study locations across Massachusetts, Mississippi, Missouri, Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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