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Recruiting NCT06524726

The International PNH Interest Group PNH Registry

Trial Parameters

Condition Paroxysmal Nocturnal Hemoglobinuria
Sponsor International PNH Interest Group
Study Type OBSERVATIONAL
Phase N/A
Enrollment 2,000
Sex ALL
Min Age N/A
Max Age N/A
Start Date 2024-05-10
Completion 2029-05-10

Brief Summary

The aim of this International PNH Interest Group (IPIG) registry is to develop an international database to prospectively collect data on patients with PNH covering clinical outcomes, patient reported outcomes (PROs), and health-resource utilization (HRU) on all enrolled patients, as well as long term safety data.

Eligibility Criteria

Inclusion Criteria: * Patients with PNH confirmed by flow cytometry. * Patient and/or parent/legally authorized representative provide written informed consent/assent to participate in the registry in a manner approved by the Institutional Review Board/Independent Ethics Committee and local regulations. Exclusion Criteria: * Participating in an interventional PNH clinical trial. Note: A patient included in the registry, who enrolls in an interventional PNH clinical trial during the course of the registry, will be kept in the registry but data collection will be paused in the registry during their involvement in the clinical trial/extension study. Data collection in the registry will continue after patient involvement in the clinical trial/extension study has ended or trial protocol mandated data collection ceases.

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