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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: Completed NA study, sponsored by Spark Therapeutics.

NCT03893240 is a NA study that has completed, run by Spark Therapeutics. The registered enrollment target is 61 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The neutralizing antibodies titer to SPK-3006 is measured once prospectively at one site visit.

Interventions

  • DIAGNOSTIC_TEST Neutralizing Antibody to SPK-3006 capsid

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2019-06-12
Est. Completion 2020-10-27
Phase NA
Spark Therapeutics

13 total trials

What the finished NCT03893240 record still lists

NCT03893240 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 1 intervention - of which Neutralizing Antibody to SPK-3006 capsid is the first listed.

NCT03893240 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT03893240's enrollment target sits among peer trials

61 1164th of 2000 higher than 837 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03893240, the US trial registry maintained by the National Library of Medicine. NCT03893240 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.