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NCT03734588 · ClinicalTrials.gov registry record · Phase 1
Dose-finding Study of SPK-8016 Gene Therapy in Patients With Hemophilia A to Support Evaluation in Individuals With FVIII Inhibitors
A Phase 1 study of Genetic Diseases, Inborn and Blood Coagulation Disorder, sponsored by Spark Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
- 11
- Study locations
NCT03734588 is a Phase 1 study of Genetic Diseases, Inborn and Blood Coagulation Disorder that has completed, run by Spark Therapeutics. The registered enrollment target is 4 participants, below the 188-participant average among 5 other Genetic Diseases, Inborn trials with a reported enrollment target (98% lower). The trial reports 11 study locations across 8 states.
The verdict
NCT03734588, a Phase 1 study of Genetic Diseases, Inborn and Blood Coagulation Disorder, has completed, sponsored by Spark Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
- 11
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- GENETIC SPK-8016
Study Locations (11)
Pennsylvania
- Penn State Health - Hershey
- Children's Hospital of Philadelphia - Philadelphia
- Jefferson University Hospitals - Philadelphia
- Hemophilia Center of Western Pennsylvania - Pittsburgh
California
- Orthopaedic Institute for Children - Los Angeles
Illinois
- Illinois Bleeding and Clotting Disorders Institute - Peoria
Michigan
- University of Michigan - Ann Arbor
Mississippi
- Mississippi Center for Advanced Medicine - Madison
New York
- Weill Cornell Medicine - New York
Oregon
- Oregon Health & Science University - Portland
Virginia
- Virginia Commonwealth University School of Medicine - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2019-01-30 |
| Est. Completion | 2023-01-19 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03734588
The ClinicalTrials.gov registry entry for NCT03734588 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 188-participant average among 5 other Genetic Diseases, Inborn trials with a reported enrollment target (98% lower). The listed sponsor is Spark Therapeutics, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Genetic Diseases, Inborn appearing as the primary indexed condition, and to 1 intervention - of which SPK-8016 is the first listed.
NCT03734588 reports 11 study locations spanning 8 distinct geographic areas - top geographies include Pennsylvania, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT03734588 about?
NCT03734588 is a clinical study titled "Dose-finding Study of SPK-8016 Gene Therapy in Patients With Hemophilia A to Support Evaluation in Individuals With FVIII Inhibitors". 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.
What is the current status of trial NCT03734588?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2019-01-30. Estimated completion is 2023-01-19.
What conditions does trial NCT03734588 study?
This clinical trial studies the following conditions: Genetic Diseases, Inborn, Blood Coagulation Disorder, Genetic Diseases, X-Linked, Blood Coagulation Disorders, Inherited, Factor VIII (FVIII).
What interventions are being tested in trial NCT03734588?
The interventions under investigation include: SPK-8016 (GENETIC).
Who is sponsoring clinical trial NCT03734588?
This trial is sponsored by Spark Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03734588 being conducted?
This trial has 11 study locations across California, Illinois, Michigan, Mississippi, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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