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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.
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