RecruitingPhase 3NCT05795140

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

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


Sponsor

Novartis Pharmaceuticals

Enrollment

65 participants

Start Date

May 8, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Iptcaopan 200 mg for people with atypical hemolytic uremic syndrome. The study is currently recruiting participants at 8 locations. People eligible for this study include aged 18 Years to 100 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIptcaopan 200 mg

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


Locations(9)

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

Novartis Investigative Site

Iruma-gun, Saitama, Japan

Novartis Investigative Site

Ankara, Yenimahalle, Turkey (Türkiye)

Novartis Investigative Site

Mersin, Yenisehir, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

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NCT05795140


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