RecruitingPhase 3NCT05935215

Efficacy and Safety of Switching From Anti-C5 Antibody Treatment to Iptacopan Treatment in Study Participants With Atypical Hemolytic Uremic Syndrome (aHUS)

A Multicenter, Single Arm, Open-label Study to Evaluate Efficacy and Safety of Switching From Anti-C5 Antibody Treatment to Iptacopan Treatment in Study Participants With aHUS

Sponsor

Novartis Pharmaceuticals

Enrollment

50 participants

Start Date

Feb 28, 2024

Study Type

INTERVENTIONAL

Conditions

Atypical Hemolytic Uremic Syndrome

Summary

The purpose of this Phase 3 study is to evaluate the efficacy and safety of iptacopan upon switching from anti-C5 antibody to iptacopan treatment in study 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 Iptacopan for people with atypical hemolytic uremic syndrome. The study is currently recruiting participants at 31 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

DRUGIptacopan

Open Label

Locations(31)

Novartis Investigative Site

Nanjing, Jiangsu, China

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Shanghai, China

Novartis Investigative Site

Bordeaux, France

Novartis Investigative Site

Paris, France

Novartis Investigative Site

Paris, France

Novartis Investigative Site

Rouen, France

Novartis Investigative Site

Toulouse, France

Novartis Investigative Site

Tours, France

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

Kiel, Germany

Novartis Investigative Site

Ranica, BG, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Matsumoto-shi, Nagano, Japan

Novartis Investigative Site

Iruma-gun, Saitama, Japan

Novartis Investigative Site

Bunkyo Ku, Tokyo, Japan

Novartis Investigative Site

Santiago Compostela, A Coruna, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Córdoba, Spain

Novartis Investigative Site

Málaga, Spain

Novartis Investigative Site

Seville, Spain

Novartis Investigative Site

Valencia, Spain

Novartis Investigative Site

Izmir, Balcova, Turkey (Türkiye)

Novartis Investigative Site

Köseköy, Kocaeli, Turkey (Türkiye)

Novartis Investigative Site

Ankara, Yenimahalle, Turkey (Türkiye)

Novartis Investigative Site

Mersin, Yenisehir, Turkey (Türkiye)

Novartis Investigative Site

Glasgow, Scotland, United Kingdom

Novartis Investigative Site

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Novartis Investigative Site

London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05935215

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