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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03248141
Other study ID # B1821056
Secondary ID HEMOBAFS
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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