Actively Recruiting

All Genders
ID06758271

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

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with granulomatosis with polyangiitis or microscopic polyangiitis who are treatment with avacopan
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Research site

Multiple Locations, Japan

Actively Recruiting

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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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