MedTrace Logo

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

NCT05795140 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-05-11

No results posted yet for this study

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.

Conditions

  • Atypical Hemolytic Uremic Syndrome

Interventions

DRUG

Iptcaopan 200 mg

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-08
Primary Completion
2032-07-16
Completion
2032-07-27
FDA Drug
Yes

Countries

  • Brazil
  • China
  • Czechia
  • India
  • Japan
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05795140 on ClinicalTrials.gov