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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 : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date June 29, 2016
First Posted Date July 13, 2016
Last Update Posted Date May 27, 2019
Actual Study Start Date October 14, 2016
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 8, 2016)
  • Proportion of patients on 2x weekly prophylaxis [ Time Frame: Up to 12 months ]
  • Proportion of patients on 3x weekly prophylaxis [ Time Frame: Up to 12 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02830477 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 8, 2016)
  • Composite number of reported bleeds (total, spontaneous, joint and trauma) [ Time Frame: Up to 12 months ]
  • 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
  • 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
  • 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
  • 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
  • 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
  • Incidence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to 12 months ]
  • Incidence of events of special interest, such as inhibitors [ Time Frame: Up to 12 months ]
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis
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
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.

Detailed Description Open label, prospective, non-interventional, single arm study in patients receiving KOVALTRY as prophylaxis therapy.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Hemophilia A, Congenital
Intervention Biological: Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973
unmodified, full length recombinant FVIII
Study Groups/Cohorts BAY81-8973
Previously treated patients receiving IV infusion of KOVALTRY for routine prophylaxis
Intervention: Biological: Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 8, 2016)
350
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Bayer Clinical Trials Contact (+) 1-888-8422937 clinical-trials-contact@bayer.com
Listed Location Countries Belgium,   Canada,   Colombia,   France,   Germany,   Greece,   Italy,   Luxembourg,   Netherlands,   Slovakia,   Slovenia,   Spain,   Switzerland,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02830477
Other Study ID Numbers 18559
KV1601 ( Other Identifier: Company Internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Bayer
Study Sponsor Bayer
Collaborators Not Provided
Investigators
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date May 2019