Actively Recruiting
REAL-CARE: Real-world Effectiveness of Iptacopan in Italian Patients With Paroxysmal Nocturnal Hemoglobinuria
Led by Novartis Pharmaceuticals · Updated on 2026-04-16
50
Participants Needed
7
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study evaluates iptacopan effectiveness and safety in routine clinical practice, with a focus on hematological response, transfusion avoidance, and patient-reported outcomes. The primary objective of the REAL-CARE study is to is to assess the long-term hematological response following iptacopan initiation. This will be assessed through the absolute change in hemoglobin (Hb) levels at 12 months post-initiation, and the proportion of patients who remain free from red blood cell (RBC) transfusions, prescribed as per local requirement and based on Investigator's judgment, from Day 14 through Month 12 after starting iptacopan.
CONDITIONS
Official Title
REAL-CARE: Real-world Effectiveness of Iptacopan in Italian Patients With Paroxysmal Nocturnal Hemoglobinuria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study assessments
- Male or female
- 18 years of age or older
- Documented diagnosis of Paroxysmal Nocturnal Hemoglobinuria (PNH)
- Followed at clinical sites in Italy
- Receiving iptacopan treatment as part of routine medical care or transitioned from Managed Access Program (MAP)
You will not qualify if you...
- Currently participating in an interventional clinical study related to PNH or its treatment
- Any other criteria outside those stated in the Summary of Product Characteristics (SmPC)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Novartis Investigative Site
Alessandria, AL, Italy, 15121
Actively Recruiting
2
Novartis Investigative Site
Avellino, AV, Italy, 83100
Actively Recruiting
3
Novartis Investigative Site
Brescia, BS, Italy, 25123
Actively Recruiting
4
Novartis Investigative Site
Florence, FI, Italy, 50134
Actively Recruiting
5
Novartis Investigative Site
Palermo, PA, Italy, 90146
Actively Recruiting
6
Novartis Investigative Site
Roma, RM, Italy, 00161
Actively Recruiting
7
Novartis Investigative Site
Bassano del Grappa, VI, Italy, 36061
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here