CClinicalTrials.gg
RecruitingNCT06758271Updated Jan 17, 2025

Special Drug Use-results Survey for Long-term Use(Avacopan)

An observational study in Microscopic Polyangiitis (MPA) and Granulomatosis With Polyangiitis (GPA), sponsored by Kissei Pharmaceutical Co., Ltd.. Recruiting at 1 site in Japan. Per ClinicalTrials.gov, last updated 2025-01-17.

Sponsored by Kissei Pharmaceutical Co., Ltd. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Sex
All
01

Study summary

The purpose of this survey is evaluating the safety and efficacy of long-term administration of avacopan for Japanese patients with microscopic polyangiitis or granulomatosis with polyangiitis under actual conditions of use.

Read the detailed description

The purpose of this survey is evaluating the safety and efficacy of long-term administration of avacopan for Japanese patients with microscopic polyangiitis or granulomatosis with polyangiitis under actual conditions of use.

02

Conditions studied

  • Microscopic Polyangiitis (MPA)
  • Granulomatosis With Polyangiitis (GPA)
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with granulomatosis with polyangiitis or microscopic polyangiitis who are treatment with avacopan

Eligibility criteria

Inclusion Criteria:

  • Patients with granulomatosis with polyangiitis or microscopic polyangiitis who are treatment with avacopan
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • Avacopan treatmented

    Drug: Avacopan

Interventions

  • DrugAvacopan

    oral administration

05

What researchers measure

Primary outcomes

  1. Adverse events

    Time frame: 2 years

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06758271
Lead sponsor
Kissei Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jan 3, 2025
Start date
Jul 29, 2022
Primary completion
May 31, 2028 (estimated)
Completion
May 31, 2028 (estimated)
Last update
Jan 17, 2025

Study contacts

Kazunori Abe, director
Contact
rinsyousiken@pharm.kissei.co.jp
0356843575

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion