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Understanding Hemophilia A and B Drug Dosage Administration Patterns

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ClinicalTrials.gov Identifier: NCT03248141
Recruitment Status : Terminated (Study recruitment was stopped due to difficulty in enrolling the targeted number of patients on March 21, 2018. See details in Description section.)
First Posted : August 14, 2017
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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, 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.

Study Design
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Study Type : Observational
Actual Enrollment : 10 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 : March 14, 2018
Actual Study Completion Date : March 14, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Groups and Cohorts
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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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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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Information from the National Library of Medicine

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, Older Adult
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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Information from the National Library of Medicine

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


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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Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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 27, 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