NCT06758271

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
25mo left

Started Jul 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Jul 2022May 2028

Study Start

First participant enrolled

July 29, 2022

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

January 17, 2025

Status Verified

December 1, 2024

Enrollment Period

5.8 years

First QC Date

December 26, 2024

Last Update Submit

January 15, 2025

Conditions

Microscopic Polyangiitis (MPA)Granulomatosis With Polyangiitis (GPA)

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    2 years

Study Arms (1)

Avacopan treatmented

Drug: Avacopan

Interventions

AvacopanDRUG

oral administration

Avacopan treatmented

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research site

Multiple Locations, Japan

RECRUITING

MeSH Terms

Conditions

Microscopic PolyangiitisGranulomatosis with Polyangiitis

Interventions

avacopan

Condition Hierarchy (Ancestors)

Cerebral Small Vessel DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisSystemic VasculitisVasculitisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Kazunori Abe, director

CONTACT

0356843575rinsyousiken@pharm.kissei.co.jp

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2024

First Posted

January 3, 2025

Study Start

July 29, 2022

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2028

Last Updated

January 17, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)