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NCT05395858 · ClinicalTrials.gov registry record
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
A clinical trial, sponsored by Bayer.
- Terminated
- Registry status
- 14
- Enrollment target
NCT05395858: Clinical Trial study, sponsored by Bayer.
NCT05395858 is a clinical trial that was terminated before completion, run by Bayer. The registered enrollment target is 14 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05395858 was terminated before completion, sponsored by Bayer.
- TERMINATED
- Registry status
- 14 participants
- Enrollment target
Study 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 receiv
Primary Outcome
Reported as infusions. IRB: institutional review board
Interventions
- OTHER No intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2023-01-17 |
| Est. Completion | 2023-11-06 |
Why NCT05395858 stopped before completion
NCT05395858 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 14 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which No intervention is the first listed.
NCT05395858 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05395858 about?
NCT05395858 is a clinical study titled "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". 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 l...
What is the current status of trial NCT05395858?
This trial is currently terminated. The enrollment target is 14 participants. The study started on 2023-01-17. Estimated completion is 2023-11-06.
What interventions are being tested in trial NCT05395858?
The interventions under investigation include: No intervention (OTHER).
Who is sponsoring clinical trial NCT05395858?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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