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NCT03893240 · ClinicalTrials.gov registry record · NA
Neutralizing Antibody Seroprevalence Study With a Retrospective Component in Participants With Late-Onset Pompe Disease
A NA study, sponsored by Spark Therapeutics.
- Completed
- Registry status
- NA
- Development phase
- 61
- Enrollment target
NCT03893240 is a NA study that has completed, run by Spark Therapeutics. The registered enrollment target is 61 participants.
The verdict
NCT03893240, a NA study, has completed, sponsored by Spark Therapeutics.
- COMPLETED
- Registry status
- NA
- Development phase
- 61 participants
- Enrollment target
Study Summary
The purpose of this study is to obtain information pertaining to the occurrence of antibodies to investigational SPK-3006 capsid and GAA, GAA activity and GAA antigen levels in the usual care setting of Late-Onset Pompe Disease (LOPD) participants on an enzyme replacement regimen. Additionally, a careful evaluation of laboratory and functional testing in patients with LOPD may provide information to better understand the disease features and better drive the design of a future interventional investigational gene therapy trial. An understanding of the underlying status of liver and muscle health in individuals with LOPD may also inform best surveillance during the conduct of gene therapy trials.
Interventions
- DIAGNOSTIC_TEST Neutralizing Antibody to SPK-3006 capsid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2019-06-12 |
| Est. Completion | 2020-10-27 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03893240
The ClinicalTrials.gov registry entry for NCT03893240 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 61 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 Neutralizing Antibody to SPK-3006 capsid is the first listed.
NCT03893240 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03893240 about?
NCT03893240 is a clinical study titled "Neutralizing Antibody Seroprevalence Study With a Retrospective Component in Participants With Late-Onset Pompe Disease". The purpose of this study is to obtain information pertaining to the occurrence of antibodies to investigational SPK-3006 capsid and GAA, GAA activity and GAA antigen levels in the usual care setting of Late-Onset Pompe Disease (LOPD) participants on an enzyme replacement regimen. Additionally, a ca...
What is the current status of trial NCT03893240?
This trial is currently completed. It is a NA study. The enrollment target is 61 participants. The study started on 2019-06-12. Estimated completion is 2020-10-27.
What interventions are being tested in trial NCT03893240?
The interventions under investigation include: Neutralizing Antibody to SPK-3006 capsid (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03893240?
This trial is sponsored by Spark Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
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