Condition: Paroxysmal Nocturnal Hemoglobinuria · Sponsor: Swedish Orphan Biovitrum
This is a 36-month, long-term, multicenter, observational study designed to describe the real world effectiveness of pegcetacoplan in patients with PNH. Patients meeting the eligibility criteria will be enrolled in the study and followed prospectively for approximately 36 months. Patient data will be collected from start of pegcetacoplan treatment to end of follow-up. Retrospective data on pegcetacoplan will be captured from the time of pegcetacoplan treatment initiation. Pegcetacoplan treatment data will be collected for a minimum of approximately 36 months and up to a maximum of approximately 72 months, including retrospective period depending on when the patient started pegcetacoplan treatment. After pegcetacoplan treatment discontinuation, patients will remain in the study for 8 weeks to capture any AEs. The scope of the study is to collect both retrospective and prospective data. Baseline is defined as start of pegcetacoplan treatment. The main part of the study will be prospective,collecting data on effectiveness, safety (all AEs), patient- and clinician-reported outcomes and health care resource use.
This description comes directly from the study's public registry record.
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Always discuss trial participation with your own doctor first.
| Liverpool Hospital | Liverpool, New South Wales, Australia | Recruiting |
| Calvary Mater Newcastle | Waratah, New South Wales, Australia | Recruiting |
| Sunshine Coast University Hospital | Birtinya, Queensland, Australia | Recruiting |
| Canberra Hospital | Garran, Australia | Recruiting |
| Institut Jules Bordet | Anderlecht, Belgium | Recruiting |
| AZ Sint-Jan | Bruges, Belgium | Recruiting |
| CHU Brugmann-Site Horta | Brussels, Belgium | Recruiting |
| Centre Hospitalier Universitaire de Liege | Liège, Belgium | Recruiting |
| AZ Herentals | Turnhout, Belgium | Recruiting |
| London Health Sciences Centre (LHSC) - Victoria Hospital | London, Ontario, Canada | Recruiting |
| University Health Network | Toronto, Ontario, Canada | Recruiting |
| Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'Île-de-Montréal | Montreal, Quebec, Canada | Active Not Recruiting |
+ 75 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05776472