NCT05395858

A Study to Learn More About Treatment With Damoctocog Alfa Pegol, How it is Used in Every Day Practice ("Real-World"), and How Satisfied People Who Receive Damoctocog Alfa Pegol Are in United States (US) Hemophilia Treatment Centers

REAL: A Pre-/Post-Intervention Descriptive Analysis and Cross-Sectional Survey to Evaluate Real-World Treatment Outcomes, Consumption, and Satisfaction With Damoctocog Alfa Pegol in US Hemophilia Treatment Centers

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 14 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

People with hemophilia A do not have enough of a protein found naturally in the blood called "clotting factor 8", also known as FVIII. This protein helps the blood to clump together to prevent and stop bleeding. People with lower levels of FVIII or FVIII that does not work properly may bleed for a long time from minor wounds, bleed into their joints, or have internal bleeding. The study treatment, Jivi (also called damoctocog alfa pegol), is already available as a treatment for people aged 12 years and older with hemophilia A, to help prevent bleeding, also known as "prophylactic" treatment. It works by replacing the missing FVIII, or the FVIII that does not work properly. It can also be used to stop bleeding that has already occurred and prior to surgery to prevent bleeding. The main goal of this study is to learn how damoctocog alfa pegol is used in the "real world" as a treatment in the United States (US) and how well it works and what other treatments patients use while receiving damoctocog alfa pegol treatment. It will also determine how satisfied people are with the treatment. There will be no required visits with a study doctor in this study. The study will include about 20 male or female patients in the US aged 12 years and over who have hemophilia A. All the patients in this study will have switched from their previous FVIII replacement treatment to damoctocog alfa pegol. While the patients are receiving damoctocog alfa pegol, they will complete a survey to say how they feel about the treatment. Their doctors will also record information about their treatment with damoctocog alfa pegol and how well it is working. This study will collect information from the patients' medical records and surveys. They will use this information to find out more about treatment with damoctocog alfa pegol under "real world" conditions. They will look at: * how often the patients receive damoctocog alfa pegol and how much they use * what other treatments the patients received before receiving damoctocog alfa pegol, how they used it and how much they used * how well damoctocog alfa pegol works at preventing bleeding, and how it compares to previous products used.

Conditions

• Hemophilia A

Interventions

Type	Name	Description
OTHER	No intervention	Retrospective analysis using database without any intervention assigned in the study.

Timeline

• Start date: 2023-01-17
• Primary completion: 2023-11-06
• Completion: 2023-11-06
• First posted: 2022-05-27
• Last updated: 2023-11-28

Locations

3 sites across 1 country: United States