Status:
RECRUITING
Fabhalta Capsules Specified Drug-use Survey
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
C3 Glomerulopathy
Eligibility:
All Genders
Up to 100 years
Brief Summary
The objective of this study is to evaluate the safety and effectiveness of Fabhalta in patients with C3 glomerulopathy in clinical practice.
Eligibility Criteria
Inclusion
- All patients who have used Fabhalta for C3 glomerulopathy (including patients with recurrent C3 glomerulopathy post renal transplant).
Exclusion
- Use of iptacopan for an indication not yet approved under the Clinical Trials Act or GCP (e.g., patient-requested medical treatment, investigator-initiated clinical trial)
Key Trial Info
Start Date :
September 17 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07156149
Start Date
September 17 2025
End Date
June 30 2028
Last Update
December 24 2025
Active Locations (9)
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1
Novartis Investigative Site
Nagoya, Aichi-ken, Japan, 466-8650
2
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 0040041
3
Novartis Investigative Site
Tsu, Mie-ken, Japan, 514-8507
4
Novartis Investigative Site
Takatsuki, Osaka, Japan, 5698686