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Trial record 1 of 1 for:    NCT03248141
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Understanding Hemophilia A and B Drug Dosage Administration Patterns

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03248141
Recruitment Status : Terminated (Study recruitment was stopped due to difficulty in enrolling the targeted number of patients on March 21, 2018. See details in Description section.)
First Posted : August 14, 2017
Results First Posted : May 20, 2019
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date May 31, 2017
First Posted Date August 14, 2017
Results First Submitted Date February 22, 2019
Results First Posted Date May 20, 2019
Last Update Posted Date May 20, 2019
Actual Study Start Date September 1, 2017
Actual Primary Completion Date March 14, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 22, 2019)
  • Resource Utilization Pattern [ Time Frame: From baseline up to end of study (6 months) ]
  • Dosing Pattern [ Time Frame: From baseline up to end of study (6 months) ]
Original Primary Outcome Measures
 (submitted: August 9, 2017)
  • Resource Utilization [ Time Frame: 7 months ]
    The resource utilization patterns of standard half-life factor replacement vs. extended half life factor replacement will be assessed for treatment of both hemophilia A and hemophilia B.
  • Dosing Pattern [ Time Frame: 7 months ]
    The dosing patterns of standard half-life factor replacement vs. extended half-life factor replacement will be assessed for treatment of both hemophilia A and hemophilia B.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Understanding Hemophilia A and B Drug Dosage Administration Patterns
Official Title UNDERSTANDING HEMOPHILIA A AND B DRUG DOSAGE ADMINISTRATION PATTERNS
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-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.
Condition
  • Hemophilia A
  • Hemophilia B
Intervention
  • Drug: Hemophilia B standard half-life
    Benefix
  • Drug: Hemophilia B extended half-life
    Alprolix
  • Drug: Hemophilia A standard half-life
    Xyntha and other standard half-life agents
  • Drug: Hemophilia A extended half-life
    Eloctate and Adynovate
Study Groups/Cohorts
  • Hemophilia B
    real world administration patterns and resource utilization implications
    Interventions:
    • Drug: Hemophilia B standard half-life
    • Drug: Hemophilia B extended half-life
  • Hemophilia A
    real world administration patterns and resource utilization implications
    Interventions:
    • Drug: Hemophilia A standard half-life
    • Drug: Hemophilia A extended half-life
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: February 22, 2019)
11
Original Estimated Enrollment
 (submitted: August 9, 2017)
300
Actual Study Completion Date March 14, 2018
Actual Primary Completion Date March 14, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03248141
Other Study ID Numbers B1821056
HEMOBAFS ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: 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.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2019