Understanding Hemophilia A and B Drug Dosage Administration Patterns

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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UNDERSTANDING HEMOPHILIA A AND B DRUG DOSAGE ADMINISTRATION PATTERNS

Conditions
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Hemophilia A, Hemophilia B

Intervention / Treatment
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* Drug: Hemophilia B standard half-life
* Drug: Hemophilia B extended half-life
* Drug: Hemophilia A standard half-life
* Drug: Hemophilia A extended half-life


Participation Criteria
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Eligibility Criteria
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Physician/Clinician Participants: Must be a healthcare provider Currently manages at least 10 hemophilia A and/or B patients Patient Participants: Willing and able to provide informed consent Diagnosed with hemophilia A or B Current disease severity is either moderately severe or severe with a clotting factor level of ≤5% If suffering from hemophilia A, must be currently taking moroctocog alfa (or another standard half-life treatment), rurioctocog alfa or efraloctocog alfa for at least six months. (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). If suffering from hemophilia B, must be currently taking nonacog alfa or eftrenonacog alfa for at least six months (If currently taking eftrenonacog alfa, must have switched from nonacog alfa and had been on that prior treatment for at least six months). Infuse at least 3 times per month Exclusion criteria: Female with hemophilia A or B Mild Haemophilia A or B
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hemophilia B<br>real world administration patterns and resource utilization implications | Drug: Hemophilia B standard half-life<br>* Benefix<br>Drug: Hemophilia B extended half-life<br>* Alprolix<br>|
| Hemophilia A<br>real world administration patterns and resource utilization implications | Drug: Hemophilia A standard half-life<br>* Xyntha and other standard half-life agents<br>Drug: Hemophilia A extended half-life<br>* Eloctate and Adynovate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemophilia A Factor VIII, Hemophilia B Factor IX, Cross-sectional, Epidemiological, Clinical practice, United States