Study Description
This is a global, prospective, multi-center study that is designed to assess the long-term safety and efficacy of OAV101 in patients who participated in an OAV101 clinical trial. The assessments of safety and efficacy in Study COAV101A12308 will continue for 5 years after enrollment in this study. The study is comprised of a Baseline Visit and 2 Follow-up Periods. For Follow-up Periods 1 and 2, which includes Baseline through Year 5 visits, assessments will be performed at the Investigational site. For the first 2 years (Follow-up Period 1), visits will occur every 6 months. For Years 3 to 5 (Follow-up Period 2) follow-up visits will be conducted annually. All patients will enter the study at the baseline visit and continue for 5 years.
Interventions
onasemnogene abeparvovec
Eligibility Criteria
Inclusion Criteria:
1. Participated in an OAV101 clinical trial.
2. Written informed consent must be obtained before any assessment is performed.
3. Patient/Parent/legal guardian willing and able to comply with study procedures.
Exclusion Criteria:
There are no exclusion criteria for this study.
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Randwick,New South Wales,2031,Australia
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Leuven,3000,Belgium
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Montreal,Quebec,H4a 3j1,Canada
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Chongqing,Chongqing,400010,China
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Guangzhou,Guangdong,510623,China
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Chengdu,Sichuan,610041,China
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Beijing,100069,China
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Beijing,100034,China
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Copenhagen,2100 o,Denmark
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Toulouse Cedex,31059,France
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Garches,92380,France
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Strasbourg,67000,France
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Bron Cedex,69677,France
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Roma,RM,00168,Italy
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Kurume city,Fukuoka,830-0011,Japan
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Shinjuku ku,Tokyo,162 8666,Japan
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Kuala Lumpur,50300,Malaysia
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Kuala Lumpur,59100,Malaysia
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Utrecht,3584cx,Netherlands
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Riyadh,11211,Saudi Arabia
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Singapore,119074,Singapore
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Barcelona,Catalunya,08035,Spain
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Kaohsiung,80756,Taiwan
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Taipei,10002,Taiwan
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Bangkok,10700,Thailand
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London,Wc1n 3jh,United Kingdom
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Newcastle Upon Tyne,Ne1 4lp,United Kingdom
Child Hosp Of The Kings Daughters
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Norfolk,Virginia,23507,United States
Crystal Proud
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Hanoi,100000,Vietnam
Worldwide Contacts
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