Understanding Hemophilia A and B Drug Dosage Administration Patterns

Hemophilia A Clinical Trial

Official title:

UNDERSTANDING HEMOPHILIA A AND B DRUG DOSAGE ADMINISTRATION PATTERNS

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03248141
• Other study ID #: B1821056
• Secondary ID: HEMOBAFS
• Status: Terminated
• Start date: September 1, 2017
• Est. completion date: March 14, 2018

Study information

• Verified date: February 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: March 14, 2018
• Est. primary completion date: March 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hemophilia A
• Hemophilia B

Intervention

Drug:
• Hemophilia B standard half-life
Benefix
• Hemophilia B extended half-life
Alprolix
• Hemophilia A standard half-life
Xyntha and other standard half-life agents
• Hemophilia A extended half-life
Eloctate and Adynovate

Locations

Country	Name	City	State
United States	Cook Children's Medical Center	Fort Worth	Texas
United States	University of Florida College of Medicine	Gainesville	Florida
United States	Alliance for Childhood Diseases, dba Hemophilia Treatment Center of Nevada	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resource Utilization Pattern		From baseline up to end of study (6 months)
Primary	Dosing Pattern		From baseline up to end of study (6 months)

External Links

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