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This study is to generate qualitative data to evaluate the impact of frequency of FVIII infusions on patients' satisfaction with treatment and their quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prophylaxis treatment of BAY94-9027_1 | 2 infusions per week during the extension study |
| |
| Prophylaxis treatment of BAY94-9027_2 | infusion every 5 days during the extension study |
| |
| Prophylaxis treatment of BAY94-9027_3 | every 7 days during the extension study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY94-9027 | Biological | Intravenous infusion of BAY94-9027 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative interviews (with patients) to determine patients' satisfaction | To conduct qualitative interviews with patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences satisfaction | up to 4 months |
| Qualitative interviews (with patients) to determine patients' quality of life | To conduct qualitative interviews with patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences quality of life; | up to 4 months |
| Qualitative interviews (with treating physicians) to determine patients' satisfaction | To conduct qualitative interview with clinicians who treat patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate the clinician perspective of patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences their patients' satisfaction | up to 4 months |
| Qualitative interviews (with treating physicians) to determine patients' quality of life | To conduct qualitative interview with clinicians who treat patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate the clinician perspective of patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences their patients' quality of life; | up to 4 months |
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Inclusion Criteria:
Patient is enrolled in the BAY94-9027 extension studies or is within 3 months of having completed participation in the BAY94-9027 extension studies;
Patient allocated to Arm 2, Arm 3 or Arm 4 of BAY94-9027 extension studies.
Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
Patient must be willing and able to participate in a telephone interview lasting up to 30 minutes;
Patient must have sufficient cognitive and linguistic capacities to allow them to actively participate in an interview lasting 30 minutes.
Exclusion Criteria:
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The study population consists of patients aged 18+ years who are participating in the BAY94-9027 extension studies or who are within 3 months of exiting the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland | Cleveland | Ohio | 110605 | United States |
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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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| ID | Term |
|---|---|
| D005169 | Factor VIII |
| ID | Term |
|---|---|
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011498 |
| Protein Precursors |
| D001685 | Biological Factors |