A Multi-center, Ambispective Cohort Study to Evaluate the Impact of Iptacopan for Adult Patients With PNH in China

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorNovartis Pharmaceuticals

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 18 years at the time of signing the ICF;

Patient with a documented diagnosis of PNH;

Patient who has never received complement inhibitor therapy;

Patient who is initiating iptacopan therapy; Patient who is initiating iptacopan therapy must start the first dose within 60 days of signing the ICF;

Disqualifiers

Participating in an interventional PNH clinical study;

Have an active systemic bacterial, viral (incl. COVID-19) or fungal infection within 14 days prior to first dose;

Documented with a history of recurrent invasive infections, e.g. active systemic bacterial, viral or fungal infection within 14 days prior to first dose;

Documented with a history of HIV infection;

Trial design

Treatments tested in this trial

  • LNP023

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators