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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
SPK-8016 is in development for the treatment of patients with inhibitors to FVIII. This Phase 1/2, open-label, non-randomized, dose-finding study to evaluate the safety, efficacy, and tolerability of SPK-8016 in adult males with severe hemophilia A and no measurable inhibitor against FVIII.
Study identification
- NCT ID
- NCT03734588
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- 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
- Genetic Diseases, Inborn
- Genetic Diseases, X-Linked
- Gene Therapy
- Gene Transfer
- Hematologic Diseases
- Hemorrhagic Disorders
- Recombinant
- Vector
- Inhibitors
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 30, 2019 (Actual)
- Primary completion
- Oct 14, 2020 (Actual)
- Completion
- Jan 19, 2023 (Actual)
- Last update posted
- Feb 23, 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 23, 2024 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03734588 live on ClinicalTrials.gov.