Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In this study researcher want to learn more about the change of physical activity of hemophilia A patients treated with damoctocog alfa pegol. Patients enrolled in this study will be wearing a small device measuring daily active time. Researcher will compare these physical activity data with patient's clinical data including bleeding events to gain information on how bleeding levels are related to the activity level of the patients.
The study aims to enroll about 80 patients who are at the same time also participating in the HEM-POWR study (NCT03932201) evaluating the effectiveness and safety of damoctocog alfa pegol.
The primary objective is to evaluate the change in physical non-sedentary activity as measured by the ActiGraph CentrePoint Insight Watch (ActiGraph LLC, Pensacola, Florida) after 1, 2 and 3 years of treatment with damoctocog alfa pegol.
Secondary objectives are to determine the
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemophilia A patients | Patients with hemophilia A who are being treated with Damoctocog alfa pegol (Jivi, BAY94-9027) in routine medical practice and are enrolled in Bayer-sponsored study NCT03932201 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Damoctocog alfa pegol (Jivi, BAY94-9027) | Drug | Intervention is given as part of routine medical practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time of physical non-sedentary activity per week | 30 days at baseline | |
| Time of physical non-sedentary activity per week | 30 days at year 1 | |
| Time of physical non-sedentary activity per week | 30 days at year 2 | |
| Time of physical non-sedentary activity per week | 30 days at year 3 | |
| Category of physical non-sedentary activity | The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity | 30 days at baseline |
| Category of physical non-sedentary activity | The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity | 30 days at year 1 |
| Category of physical non-sedentary activity | The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity | 30 days at year 2 |
| Category of physical non-sedentary activity | The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity | 30 days at year 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Time of physical activity per week by intensity | Intensity categories of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity | 30 days at each visit (baseline, year 1, 2 and 3) |
| Time of physical activity per week by intensity stratified by sedentary and locomotion activity |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Patients with hemophilia A receiving damoctocog alfa pegol during Bayer-sponsored study NCT03932201
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Comprehensive Care and Diagnosis of Inherited Blood Disorders | Orange | California | 92868 | United States | ||
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Intensity categories of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity. Sedentary = yes/no; locomotion = yes/no |
| 30 days at each visit (baseline, year 1, 2 and 3) |
| Association between physical activity time per week and annualized bleeding rate (ABR) | ABR from HEM-POWR study | 30 days at each visit (baseline, year 1, 2 and 3) |
| Association between physical activity time per week and joint annualized bleeding rate (JABR) | JABR from HEM-POWR study | 30 days at each visit (baseline, year 1, 2 and 3) |
| Association between physical activity time per week and hemophilia joint health score (HJHS) | HJHS from HEM-POWR study | 30 days at each visit (baseline, year 1, 2 and 3) |
| Association between physical activity time per week and PRO-scores for treatment satisfaction | Patient reported outcome (PRO) scores from the Hemophilia Treatment Satisfaction Questionnaire for Adults collected in HEM-POWR study | 30 days at each visit (baseline, year 1, 2 and 3) |
| Association between physical activity time per week and PRO-scores for health-related life quality | Patient reported outcome (PRO) scores from the Hemophilia Quality Life Measures for adults and Hemophilia Quality of Life short form for children questionnaires collected in HEM-POWR study | 30 days at each visit (baseline, year 1, 2 and 3) |
| Association between physical activity time per week and PRO-scores for work productivity/ activity impairment | Patient reported outcome (PRO) scores from the Work Productivity and Activity Impairment Scale questionnaire collected in HEM-POWR study | 30 days at each visit (baseline, year 1, 2 and 3) |
| Percentage of children (under 18) with ≥60 min per day of moderate to vigorous intensity physical activity | 30 days at each visit (baseline, year 1, 2 and 3) |
| Percentage of adults (age 18 to 64) with ≥150 min per week of moderate to vigorous intensity physical activity or with ≥75 min per week of vigorous intensity physical activity | 30 days at each visit (baseline, year 1, 2 and 3) |
| Repeated measure correlation between change in amount of non-sedentary physical activity time per week and change in annualized bleeding rate (ABR) | ABR from HEM-POWR study | 30 days at each visit (baseline, year 1, 2 and 3) |
| Repeated measure correlation between change in amount of non-sedentary physical activity time per week and change in joint annualized bleeding rate (JABR) | JABR from HEM-POWR study | 30 days at each visit (baseline, year 1, 2 and 3) |
| Actual wear time per week | 30 days at each visit (baseline, year 1, 2 and 3) |
| Percentage of actual wear time per week | 30 days at each visit (baseline, year 1, 2 and 3) |
| Tulane University |
| New Orleans |
| Louisiana |
| 70118 |
| United States |
| Many Locations | Multiple Locations | Belgium |
| Many Locations | Multiple Locations | Canada |
| Many Locations | Multiple Locations | Italy |
| Many Locations | Multiple Locations | Slovenia |
| Many Locations | Multiple Locations | Spain |
| Many Locations | Multiple Locations | Taiwan |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D005169 | Factor VIII |
| ID | Term |
|---|---|
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
Not provided
Not provided