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

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ClinicalTrials.gov Identifier: NCT02830477
Recruitment Status : Recruiting
First Posted : July 13, 2016
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief 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.


Condition or disease Intervention/treatment
Hemophilia A, Congenital Biological: Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973

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

Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Multinational Phase IV Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis
Actual Study Start Date : October 14, 2016
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : June 30, 2020


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




Primary Outcome Measures :
  1. Proportion of patients on 2x weekly prophylaxis [ Time Frame: Up to 12 months ]
  2. Proportion of patients on 3x weekly prophylaxis [ Time Frame: Up to 12 months ]

Secondary Outcome Measures :
  1. Composite number of reported bleeds (total, spontaneous, joint and trauma) [ Time Frame: Up to 12 months ]
  2. Proportion of patients in predefined prophylaxis regimen per age group and per country [ Time Frame: At the end of observational period, up to 12 months maximum ]

    Age group:

    • 0- <6 years
    • 6 - 12 years
    • 13 - <18 years
    • > 18 years

    Weekly prophylaxis dosing regimens:

    • 2 injections a week
    • 3 injections a week
    • Injected on every other day

  3. Overall prophylaxis dose IU/kg in patients per age group and per country [ Time Frame: At the end of observational period, up to 12 months maximum ]

    Age group:

    • 0- <6 years
    • 6 - 12 years
    • 13 - <18 years
    • > 18 years

  4. Number of physicians who selected the individual criteria as top 3 reason for the prophylaxis decision [ Time Frame: At baseline ]
    Physician will select top 3 reasons from 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

  5. Mean and median composite score for treatment satisfaction (Hemo-SAT) [ Time Frame: At baseline and end of observational period, up to 12 months maximum ]
    Hemo-SAT - Hemophilia treatment satisfaction questionnaire

  6. Score for treatment adherence (VERITAS-PRO) [ Time Frame: At baseline, 6 months and end of observational period, up to 12 months maximum ]
    VERITAS - Validated Hemophilia Regimen Treatment Adherence Scale-Prophylaxis

  7. Incidence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to 12 months ]
  8. Incidence of events of special interest, such as inhibitors [ Time Frame: Up to 12 months ]
  9. The number of physicians used one or more predefined KOVALTRY PK parameter(s) to define the dose in clinical practice [ Time Frame: At routine visits, up to 12 months maximum ]

    Pharmacokinectic parameters

    • Area under the curve (AUC)
    • Clearance (Cl)
    • Half-life
    • FVIII trough
    • FVIII peak levels
    • In-vivo recovery



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830477


Contacts
Contact: Bayer Clinical Trials Contact (+) 1-888-8422937 clinical-trials-contact@bayer.com

  Show 27 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02830477     History of Changes
Other Study ID Numbers: 18559
KV1601 ( Other Identifier: Company Internal )
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Previously treated patients

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants