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

November 3, 2023 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Open label, prospective, non-interventional, single arm study in patients receiving KOVALTRY as prophylaxis therapy.

Study Type

Observational

Enrollment (Actual)

313

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Multiple Locations, Belgium
  • Canada
      • Multiple Locations, Canada
  • Colombia
      • Multiple Locations, Colombia
  • France
      • Multiple Locations, France
  • Germany
      • Multiple Locations, Germany
  • Greece
      • Multiple Locations, Greece
  • Italy
      • Multiple Locations, Italy
  • Luxembourg
      • Multiple Locations, Luxembourg
  • Netherlands
      • Multiple Locations, Netherlands
  • Slovenia
      • Multiple Locations, Slovenia
  • Spain
      • Multiple Locations, Spain
  • Taiwan
      • Multiple Locations, Taiwan
  • United States
    • Alabama
      • Mobile, Alabama, United States
        • Children's Rehabilitation Services/ University of South Alabama
    • Colorado
      • Aurora, Colorado, United States
        • University of Colorado Hemophilia and Thrombosis Center
    • Florida
      • Gainesville, Florida, United States
        • University of Florida Health Cancer Center
      • Jacksonville, Florida, United States
        • Nemours Children's Clinic - Division of Pediatric Hematology/Oncology - Jacksonsville
      • Pensacola, Florida, United States
        • Nemours Children's Clinic - Pensacola
    • Michigan
      • Detroit, Michigan, United States
        • Henry Ford Hospital Adult Hemophilia and Thrombosis Treatment Center
    • Missouri
      • Saint Louis, Missouri, United States
        • Washington University Center for Bleeding and Blood Clotting Disorders
    • New York
      • Buffalo, New York, United States
        • Hemophilia Center of Western New York
    • North Carolina
      • Greenville, North Carolina, United States
        • East Carolina University - Brody School of Medicine
      • Winston-Salem, North Carolina, United States
        • Wake Forest University School of Medicine
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Children's Hospital at OU Medical Center
    • Utah
      • Salt Lake City, Utah, United States
        • Intermountain Hemophilia & Thrombosis Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Comprehensive Center for Bleeding Disorders / Blood Center of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Previously treated male patients with moderate to severe (≤ 5% FVIII:C) hemophilia A, with ≥ 50 exposure days (EDs) to any FVIII product and with or without history of inhibitors who have been prescribed KOVALTRY for a medically appropriate use will be eligible to be included into this study.

Description

Inclusion Criteria:

  • Male patients diagnosed with moderate to severe hemophilia A (≤ 5% FVIII:C (Factor VIII Coagulant activity))
  • Any age
  • ≥ 50 exposure days (EDs) to any FVIII product

  • Patients with or without history of inhibitors

    • Patient with previous history of inhibitors, with at least 2 consecutive negative inhibitor tests and on standard prophylaxis therapy for at least 1 year prior to study entry

    • No current evidence of FVIII inhibitor or clinical suspicion of FVIII inhibitor

      • Evidence of FVIII inhibitor as measured by the Nijmegen-modified Bethesda assay [<0.6 Bethesda units (BU/mL)] or Bethesda assay [< 1.0 BU/mL] in 2 on consecutives samples
      • Documented or clinical suspicion of shortened FVIII half-life (< 6 hrs)
  • Currently on or plan to start prophylaxis therapy with KOVALTRY
  • Written informed consent

Exclusion Criteria:

  • Patients participating in an investigational program with interventions outside of routine clinical practice
  • Patients with an additional diagnosis of any bleeding/coagulation disorder other than hemophilia A
  • Patients on Immune Tolerance Induction (ITI) treatment at the time of enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BAY81-8973
Previously treated patients receiving IV infusion of KOVALTRY for routine prophylaxis
Biological: Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973
unmodified, full length recombinant FVIII

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients on 2x and 3x weekly prophylaxis at end of observation period
Time Frame: Up to 2 years
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized composite number of reported bleeds (total, spontaneous, joint and trauma)
Time Frame: Up to 2 years
Up to 2 years
Proportion of patients in predefined prophylaxis regimen per age group and per country
Time Frame: At the end of observational period, up to 2 years

Age group: 0 to <6, ≥6 to <12, ≥12 to <18, 18 and above

Weekly prophylaxis dosing regimens:

  • 2 injections a week
  • 3 injections a week
  • Injected on every other day
At the end of observational period, up to 2 years
Physician decision determinants of prophylaxis regimen
Time Frame: At baseline
Age i.v. access Current treatment regimen Bleeding history with current treatment regimen Prior history of life threatening bleed Number of target joints Pharmacokinetic data Adherence/Compliance history Activity level Patient/caregiver preference Caregiver support Insurance coverage (US) Institution guidelines Country guidelines Other
At baseline
Change from baseline to one year and two years in treatment satisfaction (Hemo-SAT)
Time Frame: At baseline, 1 year and end of observational period, up to 2 years
Hemo-SAT - Hemophilia treatment satisfaction questionnaire
At baseline, 1 year and end of observational period, up to 2 years
Change from baseline to six months, one year and two years in Validated Hemophilia Regimen Treatment Adherence Scale-Prophylaxis (VERITAS-PRO)
Time Frame: At baseline, 6 months and end of observational period, up to 2 years
VERITAS - Validated Hemophilia Regimen Treatment Adherence Scale-Prophylaxis
At baseline, 6 months and end of observational period, up to 2 years
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Up to 2 years
Up to 2 years
Type of data relating to KOVALTRY PK
Time Frame: At routine visits, up to 2 years

Pharmacokinectic (PK) parameters

  • Area under the curve (AUC)
  • Clearance (Cl)
  • Half-life
  • FVIII trough
  • FVIII peak levels
  • In-vivo recovery
At routine visits, up to 2 years
The total annualized factor consumption (injections)
Time Frame: Up to 2 years
Up to 2 years
Change in prophylaxis dosing frequency (study start to end of observation period)
Time Frame: At baseline and end of observation period, up to 2 years
At baseline and end of observation period, up to 2 years
Reasons for selection of initial dose / dosing frequency of Kovaltry (study start to end of observation period)
Time Frame: At baseline and end of observation period, up to 2 years
At baseline and end of observation period, up to 2 years
Number of KOVALTRY PK assessments performed
Time Frame: At routine visits, up to 2 years
At routine visits, up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2016

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

June 29, 2016

First Submitted That Met QC Criteria

July 8, 2016

First Posted (Estimated)

July 13, 2016

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 3, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18559
  • KV1601 (Other Identifier: Company Internal)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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