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NCT03876301 · ClinicalTrials.gov registry record
Lead-in Study to Collect Prospective Efficacy and Safety Data of Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Participants
A clinical trial, sponsored by Spark Therapeutics.
- Completed
- Registry status
- 25
- Enrollment target
NCT03876301: Completed study, sponsored by Spark Therapeutics.
NCT03876301 is a clinical trial that has completed, run by Spark Therapeutics. The registered enrollment target is 25 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03876301 has completed, sponsored by Spark Therapeutics.
- COMPLETED
- Registry status
- 25 participants
- Enrollment target
Study Summary
The aim of this prospective, observational study is to establish a dataset on the frequency of bleeding events, as well as other characteristics of bleeding events and FVIII infusions, in patients with clinically severe hemophilia A receiving prophylactic FVIII replacement therapy as standard of care. The data collected from this study may assist in providing baseline information for comparison to the Spark's investigational hemophilia A gene therapy in future Phase 3 studies.
Primary Outcome
Annualized bleeding rate (ABR)
Interventions
- DRUG Standard of Care FVIII Replacement therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2019-01-21 |
| Est. Completion | 2023-05-02 |
What the finished NCT03876301 record still lists
NCT03876301 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 25 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Standard of Care FVIII Replacement therapy is the first listed.
NCT03876301 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03876301 about?
NCT03876301 is a clinical study titled "Lead-in Study to Collect Prospective Efficacy and Safety Data of Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Participants". The aim of this prospective, observational study is to establish a dataset on the frequency of bleeding events, as well as other characteristics of bleeding events and FVIII infusions, in patients with clinically severe hemophilia A receiving prophylactic FVIII replacement therapy as standard of car...
What is the current status of trial NCT03876301?
This trial is currently completed. The enrollment target is 25 participants. The study started on 2019-01-21. Estimated completion is 2023-05-02.
What interventions are being tested in trial NCT03876301?
The interventions under investigation include: Standard of Care FVIII Replacement therapy (DRUG).
Who is sponsoring clinical trial NCT03876301?
This trial is sponsored by Spark Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
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