Dose-finding Study of SPK-8016 Gene Therapy in Patients With Hemophilia A to Support Evaluation in Individuals With FVIII Inhibitors
Public ClinicalTrials.gov record NCT03734588. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Study identification
- NCT ID
- NCT03734588
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Lead sponsor
- Spark Therapeutics, Inc.
- Industry
- Enrollment
- 4 participants
Conditions and interventions
Conditions
- Adeno-Associated Virus (AAV)
- Blood Coagulation Disorder
- Blood Coagulation Disorders, Inherited
- Coagulation Protein Disorders
- Factor VIII (FVIII)
- Factor VIII (FVIII) Deficiency
- Factor VIII (FVIII) Gene
- Factor VIII (FVIII) Protein
- Gene Therapy
- Gene Transfer
- Genetic Diseases, Inborn
- Genetic Diseases, X-Linked
- Hematologic Diseases
- Hemorrhagic Disorders
- Inhibitors
- Recombinant
- Vector
Interventions
- SPK-8016 Genetic
Genetic
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 29, 2019
- Primary completion
- Oct 13, 2020
- Completion
- Jan 18, 2023
- Last update posted
- Feb 22, 2024
2019 – 2023
United States locations
- U.S. sites
- 11
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Orthopaedic Institute for Children | Los Angeles | California | 90007 | — |
| Illinois Bleeding and Clotting Disorders Institute | Peoria | Illinois | 61615 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Mississippi Center for Advanced Medicine | Madison | Mississippi | 39110 | — |
| Weill Cornell Medicine | New York | New York | 10065 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Penn State Health | Hershey | Pennsylvania | 17033 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Jefferson University Hospitals | Philadelphia | Pennsylvania | 19107 | — |
| Hemophilia Center of Western Pennsylvania | Pittsburgh | Pennsylvania | 15213 | — |
| Virginia Commonwealth University School of Medicine | Richmond | Virginia | 23219 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03734588, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 22, 2024 · Synced May 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03734588 live on ClinicalTrials.gov.