Actively Recruiting
Evaluate Long-term Safety, Tolerability and Efficacy of Iptacopan in Study Participants With aHUS
Led by Novartis Pharmaceuticals · Updated on 2026-05-11
65
Participants Needed
8
Research Sites
428 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluate Long-term Safety, Tolerability and Efficacy of Iptacopan in Study Participants With aHUS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before joining the study
- Willing and able to follow the study schedule
- Completed treatment in a prior Novartis-sponsored iptacopan Phase 3 trial in aHUS and still benefiting from iptacopan
- Up-to-date vaccinations against Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae according to local guidelines
You will not qualify if you...
- Receiving treatment with any complement inhibitor or prohibited drugs
- Having any medical condition that could increase risk, including active serious infections or cancer as judged by the investigator
- Active infection or history of repeated invasive infections caused by Neisseria meningitidis, Streptococcus pneumoniae, or Haemophilus influenzae
- History of allergic reaction to iptacopan or similar drugs
- Pregnant or breastfeeding women
- Women able to become pregnant unless using effective contraception during and for 1 week after treatment
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 05403 000
Active, Not Recruiting
2
Novartis Investigative Site
Rio de Janeiro, Brazil, 22270-060
Actively Recruiting
3
Novartis Investigative Site
Beijing, China, 100034
Actively Recruiting
4
Novartis Investigative Site
Ostrava, Poruba, Czechia, 708 52
Actively Recruiting
5
Novartis Investigative Site
Nagpur, Maharashtra, India, 440015
Active, Not Recruiting
6
Novartis Investigative Site
Pune, Maharashtra, India, 411011
Actively Recruiting
7
Novartis Investigative Site
Iruma-gun, Saitama, Japan, 3500495
Actively Recruiting
8
Novartis Investigative Site
Mersin, Yenisehir, Turkey (Türkiye), 33110
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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