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

NCT04543357

Last updated date
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Household Contacts
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Males or females who weigh at least 9 kg

2. Anticipated to be living or working in the same household (> or = 10 hours per week and expected to have direct contact with the participant) as a participant in the Phase 3 interventional study, C3391003, for at least 4 months from the time of the screening visit. The participant in C3391003 must have completed their Baseline Visit, but not yet have received IP as part of C3391003

3. The C3391003 participant is subsequently dosed with study intervention after the Baseline Visit

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Prior treatment with gene therapy utilizing AAV vectors of any serotype.


2. Living or working in a household where 5 other participants are already participating
in this study (C3391007).

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Household ContactsA Study to Evaluate AAV9 Neutralizing Antibody Seroconversion in Household Contacts.
NCT04543357
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title A Study to Evaluate AAV9 Neutralizing Antibody Seroconversion in Household Contacts.
Official Title A LOW-INTERVENTIONAL STUDY OF AAV9 NEUTRALIZING ANTIBODY SEROCONVERSION IN HOUSEHOLD CONTACTS OF PARTICIPANTS WITHIN THE C3391003 CLINICAL TRIAL
Brief Summary This study will include male and female participants who live or work in the same household as a participant in the Phase 3 interventional study, C3391003. 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 participant in study C3391003 who is treated with PF-06939926 gene therapy.
Detailed Description

This single center study to include approximately 50 to 250 participants is designed to estimate the likelihood of NAb seroconversion to AAV9 because of exposure to shed viral vector material released by a DMD participant treated with PF-06939926 in study C3391003. Eligible participants will undergo a blood draw provided by a Home Health Care Vendor at three home visits.

To maintain the blinded nature of study C3391003, all C3391007 study participants and investigators as well as the sponsor will remain blinded to the Cohort assignment of the C3391003 study participant in the same household until C3391003 becomes unblinded. Additionally, the detailed individual results will be considered sensitive clinical data and will not be shared with the participants, investigators, or the Sponsor until study C3391003 becomes unblinded.

The total duration of participation in the study is up to 4 months, including up to 48 days for the screening/baseline period and up to 66 days after dosing of investigational product in the C3391003 participant of the same household.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood
Sampling Method Non-Probability Sample
Study Population This single center study will include approximately 50 to 250 participants who live or work in the same household as a participant in the Phase 3 interventional study, C3391003. Up to 5 participants from the same household may be enrolled.
Condition Household Contacts
Intervention Other: Blood Draw
Blood Samples for NAb and ADA to AAV9
Study Groups/Cohorts All participants
Household contacts of a participant in study C3391003
Intervention: Other: Blood Draw
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: September 2, 2020)
250
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 23, 2021
Estimated Primary Completion Date August 23, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Males or females who weigh at least 9 kg
  2. Anticipated to be living or working in the same household (> or = 10 hours per week and expected to have direct contact with the participant) as a participant in the Phase 3 interventional study, C3391003, for at least 4 months from the time of the screening visit. The participant in C3391003 must have completed their Baseline Visit, but not yet have received IP as part of C3391003
  3. The C3391003 participant is subsequently dosed with study intervention after the Baseline Visit

Exclusion Criteria:

  1. Prior treatment with gene therapy utilizing AAV vectors of any serotype.
  2. Living or working in a household where 5 other participants are already participating in this study (C3391007).
Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04543357
Other Study ID Numbers C3391007
ARISEN ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2020