NCT03248141

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 14, 2017

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 20, 2019

Completed
Last Updated

May 20, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

May 31, 2017

Results QC Date

February 22, 2019

Last Update Submit

February 22, 2019

Conditions

Hemophilia AHemophilia B

Keywords

Hemophilia A Factor VIIIHemophilia B Factor IXCross-sectionalEpidemiologicalClinical practiceUnited States

Outcome Measures

Primary Outcomes (2)

  • Resource Utilization Pattern

    From baseline up to end of study (6 months)

  • Dosing Pattern

    From baseline up to end of study (6 months)

Study Arms (2)

Hemophilia B

real world administration patterns and resource utilization implications

Drug: Hemophilia B standard half-lifeDrug: Hemophilia B extended half-life

Hemophilia A

real world administration patterns and resource utilization implications

Drug: Hemophilia A standard half-lifeDrug: Hemophilia A extended half-life

Interventions

Hemophilia B standard half-lifeDRUG

Benefix

Hemophilia B
Hemophilia B extended half-lifeDRUG

Alprolix

Hemophilia B
Hemophilia A standard half-lifeDRUG

Xyntha and other standard half-life agents

Hemophilia A
Hemophilia A extended half-lifeDRUG

Eloctate and Adynovate

Hemophilia A

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with either hemophilia A or B who present for a routine Clinical visit will be asked to participate in the study by the treating physician at participating hemophilia treatment centers in the United States of America.

You may not qualify if:

  • Female with hemophilia A or B
  • Mild Haemophilia A or B

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Florida College of Medicine

Gainesville, Florida, 32610, United States

Location

Alliance for Childhood Diseases, dba Hemophilia Treatment Center of Nevada

Las Vegas, Nevada, 89109, United States

Location

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

Location

Related Links

MeSH Terms

Conditions

Hemophilia AHemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-Linked

Limitations and Caveats

Since study terminated early due to difficulty in enrolling targeted number of participants, so data was not collected and analyzed for any secondary endpoints, hence not reported in results. No safety concerns involved in decision to stop enrollment

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2017

First Posted

August 14, 2017

Study Start

September 1, 2017

Primary Completion

March 14, 2018

Study Completion

March 14, 2018

Last Updated

May 20, 2019

Results First Posted

May 20, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Locations

US(3)