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Trial record 1 of 1 for:    B1821056
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Understanding Hemophilia A and B Drug Dosage Administration Patterns

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03248141
First Posted: August 14, 2017
Last Update Posted: October 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose

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 Intervention
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
Study Design: Observational Model: Cohort
Time Perspective: Other
Official Title: Understanding Hemophilia A And B Drug Dosage Administration Patterns

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 300
Actual Study Start Date: June 1, 2017
Estimated Study Completion Date: December 31, 2017
Estimated Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

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, 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
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, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-9830
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03248141     History of Changes
Other Study ID Numbers: B1821056
HEMOBAFS ( Other Identifier: Alias Study Number )
First Submitted: May 31, 2017
First Posted: August 14, 2017
Last Update Posted: October 25, 2017
Last Verified: October 2017
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