Real-life Treatment Outcomes of Ravulizumab in PNH (PNH-RECORD)

AstraZeneca

Status: Active, not recruiting

Conditions: Paroxysmal Nocturnal Haemoglobinuria

Treatments: Drug: Ravulizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT06633536

D9289R00001

Details and patient eligibility

About

The PNH-RECORD study, a Polish multicenter observational (non-interventional), open-label, retrospective with prospective follow-up.

Full description

PNH-RECORD study aims to aims to collect data on the patients' characteristics and clinical outcomes of ravulizumab administered in the scope of routine clinical practice in PNH.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult (aged ≥18) patients with PNH receiving ravulizumab treatment in the frames of NDP in Poland.
2. Patients willing to participate in the study and signed ICF.

Exclusion criteria

1. Those who participated in ravulizumab clinical trial in the past, and/or those who participated/plans to participate in clinical trial on/after the date of first ravulizumab infusion through NDP.
2. Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Trial design

64 participants in 1 patient group

Ravulizumab group

Description:

Open-label

Treatment:

Drug: Ravulizumab