Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00515710 · ClinicalTrials.gov registry record
LTFU for Gene Transfer Subjects With Hemophilia B
A clinical trial, sponsored by Spark Therapeutics.
- Completed
- Registry status
- 4
- Enrollment target
NCT00515710 is a clinical trial that has completed, run by Spark Therapeutics. The registered enrollment target is 4 participants.
The verdict
NCT00515710 has completed, sponsored by Spark Therapeutics.
- COMPLETED
- Registry status
- 4 participants
- Enrollment target
Study Summary
Several subjects enrolled in a multi-site, gene transfer clinical study to evaluate the intrahepatic administration of AAV2-hFIX16 vector for the treatment of severe hemophilia B between 2001 and 2009. As the US FDA has established guidelines for the long-term follow-up (LTFU) of subjects receiving investigational gene therapy products, this protocol seeks to characterize the clinical outcome and the type and seriousness of adverse events following the AAV gene transfer. The primary study tools will consist of annual history/physical examination and blood tests, as well as periodic liver ultrasound, to characterize clinical outcomes. Where possible, data will be obtained for up to 15 years following hepatic AAV2-hFIX16 gene transfer.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2007-08 |
| Est. Completion | 2017-12 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00515710
The ClinicalTrials.gov registry entry for NCT00515710 describes a study currently listed as completed, categorized as an unspecified phase. 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 0 interventions.
NCT00515710 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00515710 about?
NCT00515710 is a clinical study titled "LTFU for Gene Transfer Subjects With Hemophilia B". Several subjects enrolled in a multi-site, gene transfer clinical study to evaluate the intrahepatic administration of AAV2-hFIX16 vector for the treatment of severe hemophilia B between 2001 and 2009. As the US FDA has established guidelines for the long-term follow-up (LTFU) of subjects receiving ...
What is the current status of trial NCT00515710?
This trial is currently completed. The enrollment target is 4 participants. The study started on 2007-08. Estimated completion is 2017-12.
Who is sponsoring clinical trial NCT00515710?
This trial is sponsored by Spark Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.