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NCT04543357 · ClinicalTrials.gov registry record
A Study to Evaluate AAV9 Neutralizing Antibody Seroconversion in Household Contacts.
A clinical trial, sponsored by Pfizer.
- Terminated
- Registry status
- 8
- Enrollment target
NCT04543357: Clinical Trial study, sponsored by Pfizer.
NCT04543357 is a clinical trial that was terminated before completion, run by Pfizer. The registered enrollment target is 8 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04543357 was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- 8 participants
- Enrollment target
Study Summary
This study will include male and female participants who live or work in the same household as a patient in one of the fordadistrogene movaparvovec interventional studies. Up to 5 participants from the same household may be enrolled. The objective is to estimate the likelihood of NAb seroconversion to AAV9 in household contacts of a patient in one of the interventional studies who is treated with fordadistrogene movaparvovec gene therapy.
Primary Outcome
Development of NAb to AAV9 was defined by an increase of \>=6-fold above Baseline titer in participants with a detectable, but negative test (ie, titer \>=1 and \<4) for NAb to AAV9 at Baseline. If there was an undetectable titer at Baseline (ie, titer \<1), then development of NAb to AAV9 was defined by a NAb to AAV9 titer \>=6.
Interventions
- OTHER Blood Draw
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2022-08-17 |
| Est. Completion | 2024-02-27 |
Why NCT04543357 stopped before completion
NCT04543357 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 8 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Blood Draw is the first listed.
NCT04543357 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04543357 about?
NCT04543357 is a clinical study titled "A Study to Evaluate AAV9 Neutralizing Antibody Seroconversion in Household Contacts.". This study will include male and female participants who live or work in the same household as a patient in one of the fordadistrogene movaparvovec interventional studies. Up to 5 participants from the same household may be enrolled. The objective is to estimate the likelihood of NAb seroconversion ...
What is the current status of trial NCT04543357?
This trial is currently terminated. The enrollment target is 8 participants. The study started on 2022-08-17. Estimated completion is 2024-02-27.
What interventions are being tested in trial NCT04543357?
The interventions under investigation include: Blood Draw (OTHER).
Who is sponsoring clinical trial NCT04543357?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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