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The purpose of this study is to collect data around the period of the conversion from plasma-derived Factor IX (pdFIX) to BeneFIX. The main information collected will be: a retrospective history of the bleedings in the 3-month period before the conversion, the recovery with pdFIX just before the conversion and with BeneFIX just after the conversion, and a prospective history of the bleedings in the 3 month period following the conversion.
The switch to BeneFIX has already been decided by the investigator. Patients will be followed up to 3 months after the switch.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Factor IX recovery | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Efficacy | Clinical efficacy was measured by number/location of bleeding episodes, number of injections per bleeding, factor IX consumption, global assessment of efficacy by investigator and patient; biological efficacy (recovery) with BeneFIX was measured just after conversion. | 4 months |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Lambert | Le Kremlin-Bicêtre | 94275 | France | |||
| Pr Chambost |
Before enrollment there was up to a 14 day screening period and the investigator reviewed the subject's medical history and medications to ensure that the subject was in good health and met all of the inclusion criteria and none of the exclusion criteria.
Patients were recruited in France from May 2008 to January 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | BeneFIX | Plasma-derived FIX recovery with a dose of 50 ± 5 IU/kg before the conversion, BeneFIX recovery with a dose of 50 ± 5 IU/kg after the conversion, treatment with BeneFIX during the next 3 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BeneFIX | Plasma-derived FIX recovery with a dose of 50 ± 5 IU/kg before the conversion, BeneFIX recovery with a dose of 50 ± 5 IU/kg after the conversion, treatment with BeneFIX during the next 3 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Reporting Efficacy | Clinical efficacy was measured by number/location of bleeding episodes, number of injections per bleeding, factor IX consumption, global assessment of efficacy by investigator and patient; biological efficacy (recovery) with BeneFIX was measured just after conversion. | Intent to Treat (ITT) population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided. | Posted | Jan 2010 | Number | Participants | 4 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BeneFIX | Plasma-derived FIX recovery with a dose of 50 ± 5 IU/kg before the conversion, BeneFIX recovery with a dose of 50 ± 5 IU/kg after the conversion, treatment with BeneFIX during the next 3 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Herpes simplex type-2 (HSV-2) meningitis | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| U. S. Contact Center | Wyeth | clintrialresults@wyeth.com |
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| ID | Term |
|---|---|
| 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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| Marseille |
| 13385 |
| France |
| Dr. Hassoun | Montmorency | 95160 | France |
| Pr Schved | Montpellier | 34291 | France |
| Dr. Rothschild | Paris | 75743 | France |
| Dr. Duillet | Rennes | 35033 | France |
| Dr. Borg | Rouen | 76031 | France |
| Pr Gruel | Tours | 37044 | France |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| 1 |
| 1 |
| 1 |
| 1 |
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Acute renal failure | Renal and urinary disorders | Non-systematic Assessment |
|
| Lower back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |