Actively Recruiting
Long-term Observational Study of Avacopan Use for Microscopic Polyangiitis and Granulomatosis With Polyangiitis
Led by Kissei Pharmaceutical Co., Ltd. · Updated on 2025-01-17
250
Participants Needed
1
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of long-term use of avacopan in Japanese patients diagnosed with microscopic polyangiitis or granulomatosis with polyangiitis. These conditions involve inflammation of blood vessels and require ongoing management. The study seeks to understand how avacopan performs under real-world conditions over an extended period. Participants receive avacopan through oral administration as the investigational treatment being assessed. The study focuses on patients already receiving this medication to observe its long-term impact. No other treatment groups or comparators are mentioned. Throughout the study, researchers monitor participants for adverse events over a two-year timeframe to assess safety. The survey collects data on the efficacy and safety outcomes associated with continued avacopan use. The total duration and specific assessment schedules are designed to capture meaningful long-term information about the treatment's performance in daily clinical practice.
CONDITIONS
Official Title
Special Drug Use-results Survey for Long-term Use(Avacopan)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with granulomatosis with polyangiitis or microscopic polyangiitis who are treatment with avacopan
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Research site
Multiple Locations, Japan
Actively Recruiting
Research Team
K
Kazunori Abe, director
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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