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NCT01620801 · ClinicalTrials.gov registry record · Phase 1
Hemophilia B Gene Therapy With AAV8 Vector
A Phase 1 study, sponsored by Spark Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT01620801 is a Phase 1 study that was terminated before completion, run by Spark Therapeutics. The registered enrollment target is 4 participants.
The verdict
NCT01620801, a Phase 1 study, was terminated before completion, sponsored by Spark Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
Hemophilia B is a bleeding disease in males due to very low levels of coagulation factor IX (FIX) in the blood. The current treatment is intravenous injection of FIX clotting factor concentrates, in response to bleeding. This study will focus on the severe, most common type of hemophilia B. This study plans to use a virus called adeno-associated virus (AAV), which in nature causes no disease, and can be engineered to deliver the human FIX gene (AAV8-hFIX19 vector) to liver cells, where FIX is normally made. This study will use the AAV8-hFIX19 vector.
Interventions
- BIOLOGICAL AAV8-hFIX19
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2012-10 |
| Est. Completion | 2016-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01620801
The ClinicalTrials.gov registry entry for NCT01620801 describes a study currently listed as terminated, 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. The listed sponsor is Spark Therapeutics, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AAV8-hFIX19 is the first listed.
NCT01620801 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01620801 about?
NCT01620801 is a clinical study titled "Hemophilia B Gene Therapy With AAV8 Vector". Hemophilia B is a bleeding disease in males due to very low levels of coagulation factor IX (FIX) in the blood. The current treatment is intravenous injection of FIX clotting factor concentrates, in response to bleeding. This study will focus on the severe, most common type of hemophilia B. This stu...
What is the current status of trial NCT01620801?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2012-10. Estimated completion is 2016-03.
What interventions are being tested in trial NCT01620801?
The interventions under investigation include: AAV8-hFIX19 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01620801?
This trial is sponsored by Spark Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
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