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Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis

NCT02830477 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 313

Last updated 2023-11-07

No results posted yet for this study

Summary

The primary objective of this study is to investigate weekly prophylaxis dosing regimens used in standard clinical practice.

In addition the study will capture reported bleed rate, pattern of change in KOVALTRY prophylaxis dose \& dosing frequency, reason for choice of treatment regimen, FVIII product switch pattern, patient treatment satisfaction and adherence, KOVALTRY pharmacokinetic data (if performed), KOVALTRY consumption, as well as safety data.

Conditions

  • Hemophilia A, Congenital

Interventions

BIOLOGICAL

Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973

unmodified, full length recombinant FVIII

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-14
Primary Completion
2020-12-01
Completion
2021-03-01

Countries

  • United States
  • Belgium
  • Canada
  • Colombia
  • France
  • Germany
  • Greece
  • Italy
  • Luxembourg
  • Netherlands
  • Slovenia
  • Spain
  • Taiwan

Study Locations

More Related Trials

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 NCT02830477 on ClinicalTrials.gov