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Real-life Treatment Outcomes of Ravulizumab in PNH

NCT ID: NCT06633536

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-06

Study Completion Date

2028-08-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Paroxysmal Nocturnal Haemoglobinuria

Keywords

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Paroxysmal nocturnal haemoglobinuria PNH ravulizumab

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Ravulizumab group

Open-label

Ravulizumab

Intervention Type DRUG

open-label arm with ravulizumab administrated within the scope of routine clinical practice

Interventions

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Ravulizumab

open-label arm with ravulizumab administrated within the scope of routine clinical practice

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Bialystok, , Poland

Site Status

Research Site

Brzozów, , Poland

Site Status

Research Site

Bydgoszcz, , Poland

Site Status

Research Site

Gdansk, , Poland

Site Status

Research Site

Krakow, , Poland

Site Status

Research Site

Lodz, , Poland

Site Status

Research Site

Lublin, , Poland

Site Status

Research Site

Opole, , Poland

Site Status

Research Site

Szczecin, , Poland

Site Status

Research Site

Warsaw, , Poland

Site Status

Research Site

Wałbrzych, , Poland

Site Status

Countries

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Poland

Other Identifiers

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D9289R00001

Identifier Type: -

Identifier Source: org_study_id