Understanding Hemophilia A and B Drug Dosage Administration Patterns

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Detailed Description:

Study recruitment was stopped due to difficulty in enrolling the targeted number of patients on March 21, 2010. 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.

Study Design

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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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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.

Criteria

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Pfizer

Investigators

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

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
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