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A Study to Evaluate AAV9 Neutralizing Antibody Seroconversion in Household Contacts.
A Study to Evaluate AAV9 Neutralizing Antibody Seroconversion in Household Contacts.

NCT04543357

TerminatedN/A

Sponsor: Pfizer

Conditions: Household Contacts

Interventions: Blood Draw

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 0 Years to

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

* Males or females who weigh at least 9 kg.
* Anticipated to be living or working in the same household as a patient in one of the fordadistrogene movaparvovec interventional studies for at least 4 months.
* Anticipated to have \> 10 hours of contact per week and expected to have direct contact with the interventional study patient.
* The interventional patient is dosed in the interventional study.

Exclusion Criteria:

* Prior treatment with gene therapy utilizing AAV vectors of any serotype.
Locations (1)
  • Baltimore, Maryland, United States