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| ID | Type | Description | Link |
|---|---|---|---|
| HEMOBAFS | Other Identifier | Alias Study Number |
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Study recruitment was stopped due to difficulty in enrolling the targeted number of patients on March 21, 2018. See details in Description section.
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Study Design
A prospective observational, cross-sectional epidemiological study in U.S. site-based clinical practice settings.
30 sites will enroll approximately 300 patients
Participating patients - or their caregiver in the case of patients under the age of 18 - will be consented to participate.
Physicians complete a retrospective chart review on each enrolled patient.
Patients will complete a one-time study questionnaire.
Study recruitment was stopped due to difficulty in enrolling the targeted number of patients on March 21, 2018. Subjects currently enrolled into the study have completed the study as per protocol. There were no safety concerns involved in the decision to stop enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemophilia B | real world administration patterns and resource utilization implications |
| |
| Hemophilia A | real world administration patterns and resource utilization implications |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemophilia B standard half-life | Drug | Benefix |
| |
| Hemophilia B extended half-life |
| Measure | Description | Time Frame |
|---|---|---|
| Resource Utilization Pattern | From baseline up to end of study (6 months) | |
| Dosing Pattern | From baseline up to end of study (6 months) |
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Physician/Clinician Participants:
Patient Participants:
(If currently taking rurioctocog alfa or efraloctocog alfa, must have been switched from a standard half-life treatment and had been on that prior treatment for at least six months).
Exclusion criteria:
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Patients diagnosed with either hemophilia A or B who present for a routine Clinical visit will be asked to participate in the study by the treating physician at participating hemophilia treatment centers in the United States of America.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida College of Medicine | Gainesville | Florida | 32610 | United States | ||
| Alliance for Childhood Diseases, dba Hemophilia Treatment Center of Nevada |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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Out of 41 screened participants, 11 were enrolled in this study. Study got terminated afterwards due to difficulty in enrolling the targeted number of participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hemophilia A Cohort | Participants diagnosed with Hemophilia A (disease severity either moderate: clotting factor level of less than and equal to [<=]5 percent[%] or severe: clotting factor level of less than [<]1%), and taking Xyntha or another standard half-life treatment (Adynovate or Eloctate) for at least 6 months (if taking Adynovate or Eloctate, must have been switched from a standard half-life treatment and had been on that prior treatment for at least six months and must have infused at least 3 times per month) were observed in this study for up to 6 months. |
| FG001 | Hemophilia B Cohort | Participants diagnosed with Hemophilia B (disease severity either moderate: clotting factor level <=5% or severe: clotting factor level of <1%), and taking BeneFIX or Alprolix for at least 6 months (if received Alprolix, must had switched from BeneFIX and had been on that prior treatment for at least 6 months and must have infused at least 3 times per month), were observed in this study for up to 6 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis population included all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Hemophilia A Cohort | Participants diagnosed with Hemophilia A (disease severity either moderate: clotting factor level of less than and equal to [<=]5 percent[%] or severe: clotting factor level of less than [<]1%), and taking Xyntha or another standard half-life treatment (Adynovate or Eloctate) for at least 6 months (if taking Adynovate or Eloctate, must have been switched from a standard half-life treatment and had been on that prior treatment for at least six months and must have infused at least 3 times per month) were observed in this study for up to 6 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Resource Utilization Pattern | Data was not collected and analyzed for this outcome measure since very less number of participants were enrolled prior to study termination. | Posted | From baseline up to end of study (6 months) |
|
From baseline up to 6 months
No enrollment occurred in Hemophilia B Cohort prior to study termination.
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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 | Hemophilia A Cohort | Participants diagnosed with Hemophilia A (disease severity either moderate: clotting factor level of less than and equal to [<=]5 percent[%] or severe: clotting factor level of less than [<]1%), and taking Xyntha or another standard half-life treatment (Adynovate or Eloctate) for at least 6 months (if taking Adynovate or Eloctate, must have been switched from a standard half-life treatment and had been on that prior treatment for at least six months and must have infused at least 3 times per month) were observed in this study for up to 6 months. |
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Since study terminated early due to difficulty in enrolling targeted number of participants, so data was not collected and analyzed for any secondary endpoints, hence not reported in results. No safety concerns involved in decision to stop enrollment
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 4, 2017 | Feb 22, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 17, 2017 | Feb 22, 2019 | SAP_001.pdf |
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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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| Drug |
Alprolix |
|
| Hemophilia A standard half-life | Drug | Xyntha and other standard half-life agents |
|
| Hemophilia A extended half-life | Drug | Eloctate and Adynovate |
|
| Las Vegas |
| Nevada |
| 89109 |
| United States |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | United States |
| BG001 | Hemophilia B Cohort | Participants diagnosed with Hemophilia B (disease severity either moderate: clotting factor level <=5% or severe: clotting factor level of <1%), and taking BeneFIX or Alprolix for at least 6 months (if received Alprolix, must had switched from BeneFIX and had been on that prior treatment for at least 6 months and must have infused at least 3 times per month), were observed in this study for up to 6 months. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Hemophilia B Cohort |
Participants diagnosed with Hemophilia B (disease severity either moderate: clotting factor level <=5% or severe: clotting factor level of <1%), and taking BeneFIX or Alprolix for at least 6 months (if received Alprolix, must had switched from BeneFIX and had been on that prior treatment for at least 6 months and must have infused at least 3 times per month), were observed in this study for up to 6 months. |
|
| Primary | Dosing Pattern | Data was not collected and analyzed for this outcome measure since very less number of participants were enrolled prior to study termination. | Posted | From baseline up to end of study (6 months) |
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Hemophilia B Cohort | Participants diagnosed with Hemophilia B (disease severity either moderate: clotting factor level <=5% or severe: clotting factor level of <1%), and taking BeneFIX or Alprolix for at least 6 months (if received Alprolix, must had switched from BeneFIX and had been on that prior treatment for at least 6 months and must have infused at least 3 times per month), were observed in this study for up to 6 months. | 0 | 0 | 0 | 0 | 0 | 0 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |