Avacostar - (PASS)
Avacostar - A Post Authorization Safety Study (PASS) to Evaluate the Incidence of Safety Events of Interest in Patients Treated With Avacopan for ANCA-associated Vasculitis (AAV)
Vifor Fresenius Medical Care Renal Pharma
500 participants
Sep 11, 2023
OBSERVATIONAL
Conditions
Summary
The Avacostar PASS is a non-interventional, multi-national, prospective cohort study that will collect data from 2 cohorts of patients: those treated with avacopan for active severe AAV, and a second cohort treated with a cyclophosphamide or rituximab-based induction regimen without avacopan for active severe AAV. The overall study duration is anticipated to be up to 7 years, including a recruitment period of approximately 3 years.
Eligibility
Inclusion Criteria5
- Diagnosis of AAV (MPA or GPA), as determined by the Investigator according to their usual practice.
- Active, severe AAV at the time of commencing avacopan or non-avacopan SoC induction therapy, in the opinion of the Investigator.
- Age ≥18 years of either sex.
- Has provided written informed consent.
- Has commenced within the previous 6 months, or is planned to commence avacopan, cyclophosphamide or rituximab for the treatment of severe, active AAV outside of an interventional clinical study.
Exclusion Criteria1
- Concurrent participation in an interventional study, unless prospectively discussed and agreed with the Medical Monitor.
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Locations(35)
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NCT05897684