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Fabhalta Capsules Specified Drug-use Survey

NCT ID: NCT07156149

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-17

Study Completion Date

2028-06-30

Brief Summary

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

Detailed Description

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Conditions

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C3 Glomerulopathy

Keywords

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C3 glomerulopathy C3G Fabhalta

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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iptacopan

patients administered iptacopan in clinical practice

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

0 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Site Status RECRUITING

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Site Status RECRUITING

Novartis Investigative Site

Tsu, Mie-ken, Japan

Site Status RECRUITING

Novartis Investigative Site

Takatsuki, Osaka, Japan

Site Status RECRUITING

Novartis Investigative Site

Kusatsu, Shiga, Japan

Site Status RECRUITING

Novartis Investigative Site

Ohtsu, Shiga, Japan

Site Status RECRUITING

Novartis Investigative Site

Fuchū, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Shinjuku Ku, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Wakayama, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

Phone: +81337978748

Email: [email protected]

Novartis Pharmaceuticals

Role: CONTACT

Email: [email protected]

Other Identifiers

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CLNP023B11401

Identifier Type: -

Identifier Source: org_study_id