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 | Aplastic Anemia and MDS International Foundation (AAMDSIF) Return to top.

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

Trial Sponsor

Contact Info

Samantha McStocker
research@foliahealth.com
‪(617) 302-7843

Start Date: May 31, 2024 End Date: April 30, 2025

ClinicalTrials.gov Identifier: NCT06411626

If you are interested in learning more about your possible participation in this clinical trial, please complete the form. Your information will be forwarded directly to the sponsoring company.

Purpose: 

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.

The study will be prospective and observational, conducted over an initial period of six months per individual from the point of study enrollment. Participants will utilize the Folia mobile app to enroll, consent, and complete all study activities. Participants will be asked to track routine treatment, symptoms, changes in treatment plans, and HRQoL using the Folia Health mobile app. Monthly survey check-ins will be conducted to capture additional data inputs, with the possibility of integrating electronic health record (EHR) and/or claims data.
 

Status: 
Enrolling
Bone Marrow Disease(s): 
Associated Drug(s): 
Phase: 
Phase 4
Gender: 
Female
Male
Age Group: 
18 years and older
Accepts Healthy Volunteers: 
No
Details on clinicaltrials.gov: 
Inclusion Criteria: 
  1. Aged 18 or older
  2. US-based with a proficient understanding of and ability to read the English language
  3. Any patient with a diagnosis of PNH, regardless of current treatment use (taking iptacopan is not required).
Exclusion Criteria: 

Study participants who do not fit all inclusion criteria listed above are unable to participate in this study.

Find Out More:

Disclaimer:

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