Understanding Hemophilia A and B Drug Dosage Administration Patterns



Status:Terminated
Conditions:Anemia, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:Any
Updated:4/29/2018
Start Date:September 1, 2017
End Date:March 14, 2018

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Understanding Hemophilia A And B Drug Dosage Administration Patterns

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.

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
We found this trial at
3
sites
3450 Hull Road
Gainesville, Florida 32610
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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