Understanding Hemophilia A and B Drug Dosage Administration Patterns

NCT ID: NCT03248141

Last Updated: 2019-05-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-03-14

Brief Summary

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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

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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.

Conditions

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Hemophilia A Hemophilia B

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Hemophilia B

real world administration patterns and resource utilization implications

Hemophilia B standard half-life

Intervention Type DRUG

Benefix

Hemophilia B extended half-life

Intervention Type DRUG

Alprolix

Hemophilia A

real world administration patterns and resource utilization implications

Hemophilia A standard half-life

Intervention Type DRUG

Xyntha and other standard half-life agents

Hemophilia A extended half-life

Intervention Type DRUG

Eloctate and Adynovate

Interventions

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Hemophilia B standard half-life

Benefix

Intervention Type DRUG

Hemophilia B extended half-life

Alprolix

Intervention Type DRUG

Hemophilia A standard half-life

Xyntha and other standard half-life agents

Intervention Type DRUG

Hemophilia A extended half-life

Eloctate and Adynovate

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* Female with hemophilia A or B
* Mild Haemophilia A or B
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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University of Florida College of Medicine

Gainesville, Florida, United States

Site Status

Alliance for Childhood Diseases, dba Hemophilia Treatment Center of Nevada

Las Vegas, Nevada, United States

Site Status

Cook Children's Medical Center

Fort Worth, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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HEMOBAFS

Identifier Type: OTHER

Identifier Source: secondary_id

B1821056

Identifier Type: -

Identifier Source: org_study_id

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