Evaluation of Patient and Physician Reported Reasons for Switching Factor VIII Replacement Therapies

NCT03405337 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 160

Last updated 2018-09-27

No results posted yet for this study

Summary

This US study will assess hemophilia A patient characteristics, health history and reasons for switching or not switching from both patient/caregiver and physician perspectives. For this purpose, this research study will include hemophilia A: 1) patients who have switched from conventional therapy to new FVIII products with an improved PK profile. 2) patients who remain on conventional therapy (who have never switched) but have considered switching, including those patients who switched from conventional therapy to new FVIII products with improved pharmacokinetics and then subsequently "switched back" to conventional replacement therapy. In doing so, real world evidence will be obtained from both patient and physician perspectives offering key insights for effective therapeutic management of patients with hemophilia A and to more fully understand what drives patient switching from a patient perspective and a physician perspective.

Conditions

Interventions

DRUG

FVIII products

Adynovate, Eloctate, Afstyla, Kovaltry

DRUG

Conventional FVIII replacement therapies

Advate, Kogenate FS, Helixate, Novoeight, Nuwiq, Recombinate, Xyntha

Sponsors & Collaborators

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-14
Primary Completion
2018-06-13
Completion
2018-06-13

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03405337 on ClinicalTrials.gov