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Understanding Hemophilia A and B Drug Dosage Administration Patterns

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NCT03248141

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
University of Florida College of Medicine
Gainesville, Florida, 32610 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia A, Hemophilia B
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0+
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Female with hemophilia A or B

- Mild Haemophilia A or B

NCT03248141
Pfizer
Terminated
Understanding Hemophilia A and B Drug Dosage Administration Patterns

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Understanding Hemophilia A and B Drug Dosage Administration Patterns
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Other
Not Provided
Not Provided
Non-Probability Sample
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.
  • Hemophilia A
  • Hemophilia B
  • Drug: Hemophilia B standard half-life
    Benefix
  • Drug: Hemophilia B extended half-life
    Alprolix
  • Drug: Hemophilia A standard half-life
    Xyntha and other standard half-life agents
  • Drug: Hemophilia A extended half-life
    Eloctate and Adynovate
  • Hemophilia B
    real world administration patterns and resource utilization implications
    Interventions:
    • Drug: Hemophilia B standard half-life
    • Drug: Hemophilia B extended half-life
  • Hemophilia A
    real world administration patterns and resource utilization implications
    Interventions:
    • Drug: Hemophilia A standard half-life
    • Drug: Hemophilia A extended half-life
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
April 1, 2018
April 1, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT03248141
B1821056
HEMOBAFS ( Other Identifier: Alias Study Number )
No
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
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/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

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