RecruitingNCT07036718

NIS PDC the Efficacy and Safety of Iptacopan in Adults in Routine Clinical Practice

A Prospective, Non-interventional Study to Evaluate the Efficacy and Safety of Iptacopan in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) in Routine Clinical Practice in the Russian Federation


Sponsor

Novartis Pharmaceuticals

Enrollment

100 participants

Start Date

Jul 28, 2025

Study Type

OBSERVATIONAL

Summary

This is a prospective, non-interventional, multicenter study to evaluate the efficacy and safety of iptacopan in patients with PNH in real-world settings in Russia.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Age ≥18 years at the start of iptacopan therapy.
  • The patient is undergoing treatment with iptacopan.
  • The treating physician decided to prescribe iptacopan based on the Summary of Product Characteristics during routine clinical practice, regardless of study participation.
  • Provision of written informed consent.

Exclusion Criteria1

  • \. Any situations where iptacopan is contraindicated in accordance with the Summary of Product Characteristics.

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Locations(8)

Novartis Investigative Site

Syktyvkar, Komi, Russia

Novartis Investigative Site

Grozny, Russia

Novartis Investigative Site

Krasnodar, Russia

Novartis Investigative Site

Moscow, Russia

Novartis Investigative Site

Murmansk, Russia

Novartis Investigative Site

Saint Petersburg, Russia

Novartis Investigative Site

Saint Petersburg, Russia

Novartis Investigative Site

Yuzhno-Sakhalinsk, Russia

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NCT07036718