NIS PDC the Efficacy and Safety of Iptacopan in Adults in Routine Clinical Practice (PRIORITY- PNH)

Novartis

Status: Enrolling

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Study type: Observational

Funder types: Industry

Identifiers

NCT07036718

CLNP023C1RU03

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

100 participants in 1 patient group

iptacopan

Description:

Adults with PNH who started the iptacopan therapy