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A Multi-center, Ambispective Cohort Study to Evaluate the Impact of Iptacopan for Adult Patients With PNH in China
Led by Novartis Pharmaceuticals · Updated on 2025-12-01
80
Participants Needed
9
Research Sites
97 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The implementation of new standards for the management of PNH and the use of iptacopan in patients with PNH are expected to change the treatment landscape and improve the overall prognosis of patients. Based on these backgrounds, we plan to conduct a real-world study of iptacopan to further evaluate its impact on treatment-related outcomes, disease management, and healthcare resource utilization in Chinese patients with PNH.
CONDITIONS
Official Title
A Multi-center, Ambispective Cohort Study to Evaluate the Impact of Iptacopan for Adult Patients With PNH in China
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of signing the informed consent form
- Documented diagnosis of paroxysmal nocturnal hemoglobinuria (PNH)
- For patients without previous complement inhibitor therapy: initiating iptacopan therapy within 60 days of signing consent
- For patients previously treated with C5 complement inhibitors: stable treatment for at least three months prior to enrollment and initiating iptacopan within 60 days of signing consent
- Documented vaccination against Neisseria meningitidis and Streptococcus pneumoniae at least 2 weeks before starting iptacopan
- If urgent iptacopan treatment is needed, continuous antibiotic use is recommended until 14 days after vaccination completion
- Signed informed consent form
You will not qualify if you...
- Participation in another interventional PNH clinical study
- Active systemic bacterial, viral (including COVID-19), or fungal infection within 14 days before first dose
- History of recurrent invasive infections
- Documented HIV infection
- Pregnant, breastfeeding, or intending to conceive during the study
- Bone marrow failure as determined by low reticulocytes, platelets, and neutrophils
- Other conditions judged by the investigator as unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Novartis Investigative Site
Guangzhou, Guangdong, China, 510000
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2
Novartis Investigative Site
Shijiazhuang, Hebei, China, 050000
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3
Novartis Investigative Site
Zhengzhou, Henan, China, 450008
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4
Novartis Investigative Site
Wuhan, Hubei, China, 430030
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5
Novartis Investigative Site
Nanchang, Jiangxi, China, 330006
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6
Novartis Investigative Site
Changchun, Jilin, China, 130021
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7
Novartis Investigative Site
Tianjin, China, 300020
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8
Novartis Investigative Site
Tianjin, China, 300052
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9
Novartis Investigative Site
Wuhan, China, 430022
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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
2
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