Fabhalta Capsules Specified Drug-use Survey

NCT07156149 · tracked via the Priya Life Science Japan tracker

Sponsor

Novartis Pharmaceuticals

Phase

Observational

Started

2025-09-17

Last updated

2026-07-13

Condition(s) studied

C3 Glomerulopathy

Study summary

The objective of this study is to evaluate the safety and effectiveness of Fabhalta in patients with C3 glomerulopathy in clinical practice.

Eligibility

Sex

ALL

Min age

0 Years

Max age

100 Years

Healthy volunteers

Inclusion Criteria: * All patients who have used Fabhalta for C3 glomerulopathy (including patients with recurrent C3 glomerulopathy post renal transplant). Exclusion Criteria: * 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)

Primary outcome measure(s)

Number of patients with infections — 360 Days
Number of patients with infections and type of infections (meningococcal infection, pneumococcal infection, Haemophilus influenzae infection, and other infections based on the causative bacteria) as adverse events/adverse reactions during the treatment period

Trial sites (29)

Facility	City	Region
Novartis Investigative Site	Nagoya	Aichi-ken
Novartis Investigative Site	Toyoake	Aichi-ken
Novartis Investigative Site	Hirosaki	Aomori
Novartis Investigative Site	Chiba	Chiba
Novartis Investigative Site	Fukuoka	Fukuoka
Novartis Investigative Site	Kitakyushu	Fukuoka
Novartis Investigative Site	Sapporo	Hokkaido
Novartis Investigative Site	Sapporo	Hokkaido
Novartis Investigative Site	Tsukuba	Ibaraki
Novartis Investigative Site	Komatsu	Ishikawa-ken
Novartis Investigative Site	Yokohama	Kanagawa
Novartis Investigative Site	Tosa-gun	Kyoto
Novartis Investigative Site	Tsu	Mie-ken
Novartis Investigative Site	Nagasaki	Nagasaki
Novartis Investigative Site	Suita	Osaka
Novartis Investigative Site	Takatsuki	Osaka
Novartis Investigative Site	Kusatsu	Shiga
Novartis Investigative Site	Ohtsu	Shiga
Novartis Investigative Site	Shizuoka	Shizuoka
Novartis Investigative Site	Shimotsuga Gun	Tochigi
Novartis Investigative Site	Tokushima	Tokushima
Novartis Investigative Site	Bunkyo-ku	Tokyo
Novartis Investigative Site	Fuchū	Tokyo
Novartis Investigative Site	Nakano City	Tokyo
Novartis Investigative Site	Shinjuku Ku	Tokyo
Novartis Investigative Site	Hiroshima	Japan
Novartis Investigative Site	Ishikawa	Japan
Novartis Investigative Site	Nara	Japan
Novartis Investigative Site	Wakayama	Japan

More Novartis Pharmaceuticals trials in Japan

Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy. Recruiting

Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN Recruiting

Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Diffuse Cutaneous Systemic Sclerosis Active, not recruiting

A Study to Identify an Optimal Dose of QCZ484 in Mild to Moderate Hypertensive Patients Active, not recruiting

A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids Active, not recruiting

Other trials for the same condition

An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Participants With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis Active, not recruiting

Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07156149 on ClinicalTrials.gov ↗ ← All trials in Japan