RecruitingNCT06411626

Home Reported Outcomes in PNH

Home Reported Outcomes in PNH: A Mobile App-Based, Prospective, Observational Program to Evaluate Disease Burden and Treatment Patterns in Paroxysmal Nocturnal Hemoglobinuria in the US


Sponsor

Novartis Pharmaceuticals

Enrollment

128 participants

Start Date

Jun 11, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The study aims to longitudinally capture the full spectrum of symptoms, treatment utilization, and overall Health-Related Quality of Life (HRQoL) experienced by PNH patients. By primarily utilizing home reported outcomes (HRO) data on symptom burden and treatment usage, supplemented with patient-reported outcome (PRO) measures, the study seeks to establish a new real-world data (RWD) source to understand symptom variability and HRQoL among PNH patients, including those receiving orally administered iptacopan.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria4

  • Study participants eligible for inclusion in this study must meet all of the following criteria:
  • Aged 18 or older
  • US-based with a proficient understanding of and ability to read the English language
  • Any patient with a diagnosis of PNH, regardless of symptom or treatment history

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Interventions

OTHERPNH-relevant therapies

This is an observational study. There is no treatment allocation. The decision to initiate PNH-relevant therapies (such as eculizumab, ravulizumab, pegcetacoplan, iptacopan, and others) will be based solely on clinical judgement.


Locations(1)

Novartis Investigative Site

East Hanover, New Jersey, United States

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NCT06411626


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