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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06634836 | Registry Identifier | ClinicalTrials.gov |
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The purpose of this study is to learn about experiences of patients with hemophilia A and B after taking gene therapy. The experiences of patients will be studied through online interviews.
This study is seeking participants who are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemophilia A and Hemophilia B patients | Patients who are participating in the Pfizer's gene therapy clinical trials for Hemophilia A or Hemophilia B or are in the long-term follow up for these clinical programs |
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| Measure | Description | Time Frame |
|---|---|---|
| Frequency of self-reported symptoms pre and post hemophilia gene therapy | From date of dosing in the gene therapy clinical trial until the interview date, no less than 52 weeks. | |
| Frequency of self-reported severity pre and post hemophilia gene therapy | From date of dosing in the gene therapy clinical trial until the interview date, no less than 52 weeks. | |
| Frequency of self-reported impacts pre and post hemophilia gene therapy | From date of dosing in the gene therapy clinical trial until the interview date, no less than 52 weeks. | |
| Change in the proportion of patients answering 5-point Likert scale questions about the burden of hemophilia on the participant's life pre-post gene therapy | From date of dosing in the gene therapy clinical trial until the interview date, no less than 52 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
-No exclusion criteria
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Patients who are participating in the Pfizer's gene therapy clinical trials for Hemophilia A and B or are in the long-term follow up for these clinical programs
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D002836 | Hemophilia B |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |