Clinical trial • Phase III • Other
Clinical trial
Phase III trial. 81 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 14-10-2024
- First CTIS Authorization Date
- 03-12-2024
Trial design
Phase III trial across 1 site in Belgium.
- Target Sample Size
- 81
Eligibility
Recruits 81 No vulnerable population selected; study includes healthy adult participants; assent/consent handling not specified..
- Vulnerable Population
- No vulnerable population selected; study includes healthy adult participants; assent/consent handling not specified.
Recruitment
- Planned Sample Size
- 81
- Recruitment Window Months
- 19
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 81
Belgium
- Earliest CTIS Part Ii Submission Date
- 12-11-2024
- Latest Decision Or Authorization Date
- 21-05-2025
- Processing Time Days
- 190
- Number Of Sites
- 1
- Number Of Participants
- 81
Sites
- Site Name
- SGS Belgium
- Department Name
- SGS-Clinical Research CPU
- Contact Person Name
- Jelle Klein
- Contact Person Email
- jelle.klein@sgs.com
- Number Of Participants
- 81
Sponsor
Primary sponsor
- Full Name
- Argenx
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
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