stop_circleTerminated/Withdrawn

Hemophilia A

Bayer Identifier:

21280

ClinicalTrials.gov Identifier:

NCT05395858

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

12 - N/A
  • - 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.
  • - Diagnosis of any other bleeding/coagulation disorder other than hemophilia A.
    - Participation in any past or current damoctocog alfa pegol interventional trial.

Trial summary

Enrollment Goal
14
Trial Dates
January 2023 - November 2023
Phase
Phase 4
Could I Receive a placebo
No
Products
Jivi (Damoctocog, BAY94-9027)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Tulane UniversityNew Orleans, 70112, United States
Terminated
University of California, DavisSacramento, 95817, United States
Terminated
Regents of the University of MinnesotaMinneapolis, 55455, United States

Primary Outcome

  • Frequency of damoctocog alfa pegol infusions
    Reported as infusions. IRB: institutional review board
    date_rangeTime Frame:
    From index date through the date of central IRB approval (3 years and 8 months)

Secondary Outcome

  • Descriptive summary of pre-damoctocog alfa pegol treatment regimen
    date_rangeTime Frame:
    6 months prior to the index date.
  • Descriptive summary of damoctocog alfa pegol treatment regimen.
    date_rangeTime Frame:
    Up to 5 years from index date
  • Descriptive summary of post-damoctocog alfa pegol treatment regimen, if applicable.
    Only applicable for patients who discontinue damoctocog alfa pegol treatment regime.
    date_rangeTime Frame:
    Up to 4 years
  • Descriptive summary of changes in pre-damoctocog alfa pegol treatment regimes
    date_rangeTime Frame:
    6 months prior to the index date.
  • Descriptive summary for reasons for treatment discontinuation of pre-damoctocog alfa pegol treatment regimes.
    date_rangeTime Frame:
    6 months prior to the index date.
  • Annualized number of spontaneous, joint, and trauma bleeds before initiation of treatment with damoctocog alfa pegol.
    date_rangeTime Frame:
    6 months prior to the index date.
  • Annualized number of spontaneous, joint, and trauma bleeds post initiation of treatment with damoctocog alfa pegol.
    date_rangeTime Frame:
    Up to 5 years from index date

Trial design

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
Trial Type
Observational
Intervention Type
Other
Trial Purpose
Other
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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