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RECRUITING
NCT05795140
PHASE3

Evaluate Long-term Safety, Tolerability and Efficacy of Iptacopan in Study Participants With aHUS

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This is a multicenter, single arm, open-label, extension study to evaluate the long-term safety, tolerability, and efficacy of iptacopan in participants with aHUS.

Official title: A Multi-center, Single Arm, Open-label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Iptacopan in Participants With Atypical Hemolytic Uremic Syndrome (aHUS) Who Have Completed a Preceding Iptacopan Phase 3 Study in aHUS

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

125

Start Date

2024-05-08

Completion Date

2033-01-03

Last Updated

2025-07-16

Healthy Volunteers

No

Interventions

DRUG

Iptcaopan 200 mg

Open label, participant specific kits, hard gelatin capsules to be taken twice a day

Locations (6)

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

Rio de Janeiro, Brazil

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Ostrava, Poruba, Czechia

Novartis Investigative Site

Nagpur, Maharashtra, India

Novartis Investigative Site

Pune, Maharashtra, India