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

Hemophilia A Clinical Trial

— REAL  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05395858
• Other study ID #: 21280
• Status: Terminated
• Start date: January 17, 2023
• Est. completion date: November 6, 2023

Study information

• Verified date: November 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: November 6, 2023
• Est. primary completion date: November 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Male or female with a diagnosis of hemophilia A

• Previously or currently treated with damoctocog alfa pegol for at least 6 months.

• Treated with damoctocog alfa pegol per the US approved label to include:

• Aged =12 years at the time of damoctocog alfa pegol treatment initiation

• Previously treated for hemophilia A with an FVIII replacement therapy other than damoctocog alfa pegol

• Treatment modality of on-demand, prophylactic, intermittent prophylaxis or a combination thereof

• Have data in the medical record at the participating site as follows:

• For a minimum of 6 months prior to the damoctocog alfa pegol initiation date

• For a minimum of 6 months post-damoctocog alfa pegol initiation date AND the patient was receiving treatment with damoctocog alfa pegol during this 6-month follow-up period AND this data is dated prior to the central institutional review board (IRB) approval date for the study

• To include the FVIII replacement therapy most recently received prior to the initiation of damoctocog alfa pegol

• For patients in the prospective cohort

• Signed informed consent

• Current treatment with damoctocog alfa pegol or discontinued use of damoctocog alfa pegol within 3 months prior to the date of enrollment into the retrospective cohort.

Exclusion Criteria:

• Diagnosis of any other bleeding/coagulation disorder other than hemophilia A.

• Participation in any past or current damoctocog alfa pegol interventional trial.

Related Conditions & MeSH terms

• Hemophilia A

Intervention

Other:
• No intervention
Retrospective analysis using database without any intervention assigned in the study.

Locations

Country	Name	City	State
United States	Regents of the University of Minnesota	Minneapolis	Minnesota
United States	Tulane University	New Orleans	Louisiana
United States	University of California, Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of damoctocog alfa pegol infusions	Reported as infusions. IRB: institutional review board	From index date through the date of central IRB approval (3 years and 8 months)
Secondary	Descriptive summary of pre-damoctocog alfa pegol treatment regimen		6 months prior to the index date.
Secondary	Descriptive summary of damoctocog alfa pegol treatment regimen.		Up to 5 years from index date
Secondary	Descriptive summary of post-damoctocog alfa pegol treatment regimen, if applicable.	Only applicable for patients who discontinue damoctocog alfa pegol treatment regime.	Up to 4 years
Secondary	Descriptive summary of changes in pre-damoctocog alfa pegol treatment regimes		6 months prior to the index date.
Secondary	Descriptive summary for reasons for treatment discontinuation of pre-damoctocog alfa pegol treatment regimes.		6 months prior to the index date.
Secondary	Annualized number of spontaneous, joint, and trauma bleeds before initiation of treatment with damoctocog alfa pegol.		6 months prior to the index date.
Secondary	Annualized number of spontaneous, joint, and trauma bleeds post initiation of treatment with damoctocog alfa pegol.		Up to 5 years from index date

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