Understanding Hemophilia A and B Drug Dosage Administration Patterns

Terminated

• Conditions: Hemophilia A; Hemophilia B
• Interventions: Drug: Hemophilia B standard half-life; Drug: Hemophilia A standard half-life; Drug: Hemophilia B extended half-life; Drug: Hemophilia A extended half-life

• Registration Number: NCT03248141
• Lead Sponsor: Pfizer

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 Timeline

• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-08-09
• Study First Posted: 2017-08-14
• Study Start: 2017-09-01
• Primary Completion: 2018-03-14
• Study Completion: 2018-03-14
• Status Verified: 2019-02
• Results First Submitted: 2019-02-22
• Results First Submitted QC: 2019-02-22
• Last Update Submitted: 2019-02-22
• Results First Posted: 2019-05-20
• Last Update Posted: 2019-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hemophilia B	Hemophilia B standard half-life	real world administration patterns and resource utilization implications
Hemophilia B	Hemophilia B extended half-life	real world administration patterns and resource utilization implications
Hemophilia A	Hemophilia A standard half-life	real world administration patterns and resource utilization implications
Hemophilia A	Hemophilia A extended half-life	real world administration patterns and resource utilization implications

Primary Outcome Measures

Name	Time	Method
Resource Utilization Pattern	From baseline up to end of study (6 months)
Dosing Pattern	From baseline up to end of study (6 months)

Trial Locations

Locations (3)

University of Florida College of Medicine; 🇺🇸 Gainesville, Florida, United States

Alliance for Childhood Diseases, dba Hemophilia Treatment Center of Nevada; 🇺🇸 Las Vegas, Nevada, United States

Cook Children's Medical Center; 🇺🇸 Fort Worth, Texas, United States