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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 14, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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