Avacostar - A Post Authorization Safety Study (PASS) to Evaluate the Incidence of Safety Events of Interest in Patients Treated With Avacopan for ANCAassociated Vasculitis (AAV)

Study identification

• EU PAS number:
  EUPAS105408
• Study ID:
  106869
• Official title and acronym:
  Avacostar - A Post Authorization Safety Study (PASS) to Evaluate the Incidence of Safety Events of Interest in Patients Treated With Avacopan for ANCAassociated Vasculitis (AAV)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  United Kingdom
• Study description:
  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. Enrolled patients will be followed until the last patient last visit (LPLV) milestone, which will be 4 years after the last participant is enrolled.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Vifor Pharma

Study timelines

Date when funding contract was signed

Planned: 13/06/2022

Study start date

Planned: 01/12/2023

Actual: 11/09/2023

Date of final study report

Planned: 31/12/2030

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Vifor Fresenius Medical Care Renal Pharma Ltd

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)