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

Atypical Hemolytic Uremic Syndrome Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

The extension study Baseline/Day 1 visit is equivalent to the End of Treatment visit of the parent study. The study will begin on Day 1 followed by on-site visits every 4 months during the study treatment period. A Safety Follow Up tele-visit must be conducted 7 days after last study treatment to collect information on Adverse Events. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05795140
Study type Interventional
Source Novartis
Contact Novartis Pharmaceuticals
Phone +41613241111
Email novartis.email@novartis.com
Status Not yet recruiting
Phase Phase 3
Start date May 20, 2024
Completion date October 9, 2029
View Details
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