Brief Title
Understanding Hemophilia A and B Drug Dosage Administration Patterns
Official Title
UNDERSTANDING HEMOPHILIA A AND B DRUG DOSAGE ADMINISTRATION PATTERNS
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.
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 Type
Observational
Primary Outcome
Resource Utilization Pattern
Condition
Hemophilia A
Intervention
Hemophilia B standard half-life
Study Arms / Comparison Groups
Hemophilia B
Description: real world administration patterns and resource utilization implications
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
11
Start Date
September 1, 2017
Completion Date
March 14, 2018
Primary Completion Date
March 14, 2018
Eligibility 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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03248141
Organization ID
B1821056
Secondary IDs
HEMOBAFS
Responsible Party
Sponsor
Study Sponsor
Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
February 2019