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A Prospective Study Evaluating Seroprevalence and Seroconversion of Antibodies Against Adeno-associated Virus (AAV)

NCT ID: NCT05580692

Last Updated: 2024-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

321 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-14

Study Completion Date

2024-07-31

Brief Summary

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A prospective cohort study utilizing biospecimen sample collection from adult Hemophilia A subjects to evaluate and characterize seroprevalence and the seroconversion of antibodies against AAV serotypes

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Detailed Description

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This is a multinational, multi-center, prospective cohort study utilizing biospecimen sample collection from adult Hemophilia A subjects to evaluate and characterize seroprevalence and the seroconversion of antibodies against AAV serotypes

Conditions

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Hemophilia A

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patient Cohort

All Patients are within the same arm

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Biospecimen Sample Collection

Interventions

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Biospecimen Collection

Biospecimen Sample Collection

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adult Subjects with Hemophilia A

Exclusion Criteria

* Subject previously treated with AAV vector gene therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BioMarin Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medinfo Medinfo

Role: STUDY_DIRECTOR

BioMarin Pharmaceutical

Locations

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Instituto Hematologia Arbesu

Godoy Cruz, Mendoza Province, Argentina

Site Status

Hospital Ramon Jose Vidal

Corrientes, , Argentina

Site Status

Medico Hematologo

Mendoza, , Argentina

Site Status

Instituto de Hematologia y Medicina Clinica Dr. RUben Davoli

Rosario, , Argentina

Site Status

Royal Prince Alfred Hospital

Camperdown, , Australia

Site Status

Haemophilia and Haemostasis Centre Level 1 Cancer Centre South Metropolitan Health Service Fiona Stanley Hospital

Murdoch, , Australia

Site Status

Medical University of Vienna

Vienna, , Austria

Site Status

King Faisal Specialist Hospital & Research Center

Riyadh, , Saudi Arabia

Site Status

King Saud University Medical City King Saud University

Riyadh, , Saudi Arabia

Site Status

Skane University Hospital

Malmo, , Sweden

Site Status

ME Centrum för kliniska cancerstudier - House H3

Solna, , Sweden

Site Status

Acibadem Adana Hospital

Adana, , Turkey (Türkiye)

Site Status

Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status

Gaziantep University Medical Faculty Sahinbey Educational Research Hospital

Gaziantep, , Turkey (Türkiye)

Site Status

Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

Istanbul, , Turkey (Türkiye)

Site Status

Ege University Medical Faculty

Izmir, , Turkey (Türkiye)

Site Status

Ondokuz Mayis Univ. Med. Fac.

Samsun, , Turkey (Türkiye)

Site Status

Sheikh Shakhbout Medical City

Abu Dhabi, , United Arab Emirates

Site Status

Countries

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Argentina Australia Austria Saudi Arabia Sweden Turkey (Türkiye) United Arab Emirates

Other Identifiers

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270-702

Identifier Type: -

Identifier Source: org_study_id

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