Understanding Hemophilia A and B Drug Dosage Administration Patterns
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ClinicalTrials.gov Identifier: NCT03248141 |
Recruitment Status
:
Terminated
(See Detailed Description)
First Posted
: August 14, 2017
Last Update Posted
: April 9, 2018
|
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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.
Condition or disease | Intervention/treatment |
---|---|
Hemophilia A Hemophilia B | Drug: Hemophilia B standard half-life Drug: Hemophilia B extended half-life Drug: Hemophilia A standard half-life Drug: Hemophilia A extended half-life |
Study Type : | Observational |
Actual Enrollment : | 200 participants |
Observational Model: | Cohort |
Time Perspective: | Other |
Official Title: | Understanding Hemophilia A And B Drug Dosage Administration Patterns |
Actual Study Start Date : | September 1, 2017 |
Actual Primary Completion Date : | April 1, 2018 |
Actual Study Completion Date : | April 1, 2018 |

Group/Cohort | Intervention/treatment |
---|---|
Hemophilia B
real world administration patterns and resource utilization implications
|
Drug: Hemophilia B standard half-life
Benefix
Drug: Hemophilia B extended half-life
Alprolix
|
Hemophilia A
real world administration patterns and resource utilization implications
|
Drug: Hemophilia A standard half-life
Xyntha and other standard half-life agents
Drug: Hemophilia A extended half-life
Eloctate and Adynovate
|
- Resource Utilization [ Time Frame: 7 months ]The resource utilization patterns of standard half-life factor replacement vs. extended half life factor replacement will be assessed for treatment of both hemophilia A and hemophilia B.
- Dosing Patterns [ Time Frame: 7 months ]The dosing patterns of standard half-life factor replacement vs. extended half-life factor replacement will be assessed for treatment of both hemophilia A and hemophilia B.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248141
United States, Florida | |
University of Florida College of Medicine | |
Gainesville, Florida, United States, 32610 | |
United States, Nevada | |
Alliance for Childhood Diseases, dba Hemophilia Treatment Center of Nevada | |
Las Vegas, Nevada, United States, 89109 | |
United States, Texas | |
Cook Children's Medical Center | |
Fort Worth, Texas, United States, 76104 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT03248141 History of Changes |
Other Study ID Numbers: |
B1821056 HEMOBAFS ( Other Identifier: Alias Study Number ) |
First Posted: | August 14, 2017 Key Record Dates |
Last Update Posted: | April 9, 2018 |
Last Verified: | April 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No | |
Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by Pfizer:
Hemophilia A Factor VIII Hemophilia B Factor IX Cross-sectional |
Epidemiological Clinical practice United States |
Additional relevant MeSH terms:
Hemophilia A Hemophilia B Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases Coagulation Protein Disorders |
Hemorrhagic Disorders Genetic Diseases, Inborn Genetic Diseases, X-Linked Factor VIII Coagulants |