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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1271-9209 | Other Identifier | World Health Organization (WHO) |
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This study will collect information on the long term health of joints in people with haemophilia A who have started treatment with Esperoct within twelve months prior to participation to the study. This study is conducted to look at how joint health of people with haemophilia changes over time when they are receiving the medicine Esperoct. The participants will get Esperoct as prescribed to the participants by the study doctor. The participant's treatment will not be affected by their involvement in the study. Every six months, the participants will be asked to answer some questionnaires about their joints, their pain and their ability to be physically active. Their participation in the study will last for no more than 2 years. The participants are free to leave the study at any time and for any reason. This will not affect their current and future medical care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Haemophilia A | Participants will be treated with commercially available Esperoct for a total study duration of 24 months according to the local label and local routine clinical practice at the discretion of the physician. The decision to switch to Esperoct will be made prior to and separate from the decision to enrol in the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esperoct | Drug | Participants will be treated with commercially available Esperoct for a total study duration of 24 months according to the local label and local routine clinical practice at the discretion of the physician. The decision to switch to Esperoct will be made prior to and separate from the decision to enrol in the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in haemophilia joint health score (HJHS) | Measured as units on a score. The scoring range of the HJHS is from 0 (normal, healthy joints) to 124 (maximum severity). A sustained HJHS is defined as a change in total score of less than or equal to (<=) 2 points over 24 months. | From date of switch to end of study (up to 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| The number of bleeding episodes requiring coagulation Factor VIII (FVIII) treatment | Measured as episodes | From baseline to end of study (up to 24 months) |
| Number of target joints | Measured as number of target joints. Target joints is defined according to the International Society on Thrombosis and Haemostasis (ISTH) as any joint with greater than or equal to (>=) 3 bleeding episodes in the same joint within a 6-month period. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with Haemophilia A
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency' dept. 2834 | Novo Nordisk A/S' | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Recruiting | Hamilton | Ontario | Canada |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| From baseline to end of study (up to 24 months) |
| Resolution of any target joints (Yes/No) | Measured as number of resolutions. Target joint resolution is defined according to the ISTH as previously diagnosed target joint that has <=2 spontaneous bleeds in the target joint over 12 month. | From baseline to end of study (up to 24 months) |
| Change in patient reported Problem Joint score | Measured in score of problem joints (PJs). A PJ is defined as having chronic joint pain and/or limited range of movement due to compromised joint integrity (i.e. chronic synovitis and/or hemophilic arthropathy). PJ scores are stratified: none, 1 PJ, and 2+ PJs. | From baseline to end of study (up to 24 months) |
| Change in patient reported pain scores (Brief Pain Inventory) | Measured as units on a score. The BPI assesses pain at its "worst," "least," "average," and "current pain". | From baseline to end of study (up to 24 months) |
| Change in physical function and activity measured using patient reported outcome questionnaires (Short Form-36) | Measured as units on a score. Short form-36 (SF-36) is a 36-item patient-reported survey of patient health that measures the participants's overall health-related quality of life (HRQoL). Scores range from 0-100 (where higher scores indicate a better HRQoL) | From baseline to end of study (up to 24 months) |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |