check_circleStudy Completed

Hemophilia A, Congenital

Bayer Identifier:

18559

ClinicalTrials.gov Identifier:

NCT02830477

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study Evaluating “Real World” Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog alfa) for Routine Prophylaxis

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

NaN - N/A
  • - 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

  • - 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

Trial summary

Enrollment Goal
313
Trial Dates
October 2016 - March 2021
Phase
Phase 4
Could I Receive a placebo
No
Products
Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
many locations, Germany
Completed
many locations, France
Completed
many locations, Italy
Withdrawn
many locations, Switzerland
Completed
many locations, Belgium
Completed
many locations, Netherlands
Completed
many locations, Spain
Completed
many locations, Greece
Completed
many locations, Colombia
Completed
many locations, Taiwan
Completed
Wake Forest University School of MedicineWinston-Salem, United States
Completed
Washington University Center for Bleeding and Blood Clotting DisordersSt. Louis, United States
Completed
University of Colorado Hemophilia and Thrombosis CenterAurora, United States
Completed
Hemophilia Center of Western New YorkBuffalo, United States
Completed
Children’s Rehabilitation Services/ University of South AlabamaMobile, United States
Completed
Nemours Children’s Clinic – Division of Pediatric Hematology/Oncology – JacksonsvilleJacksonville, United States
Completed
Nemours Children’s Clinic – PensacolaPensacola, United States
Completed
Comprehensive Center for Bleeding Disorders / Blood Center of WisconsinMilwaukee, United States
Completed
Children’s Hospital at OU Medical CenterOklahoma, United States
Completed
Henry Ford Hospital Adult Hemophilia and Thrombosis Treatment CenterDetroit, United States
Completed
University of Florida Health Cancer CenterGainesville, United States
Completed
Intermountain Hemophilia & Thrombosis CenterSalt Lake City, United States
Completed
East Carolina University – Brody School of MedicineGreenville, United States
Completed
many locations, Canada
Withdrawn
many locations, Slovakia
Completed
many locations, Luxembourg
Completed
many locations, Slovenia

Primary Outcome

  • Proportion of patients on 2x and 3x weekly prophylaxis at end of observation period
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Annualized composite number of reported bleeds (total, spontaneous, joint and trauma)
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of patients in predefined prophylaxis regimen per age group and per country
    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
    date_rangeTime Frame:
    At the end of observational period, up to 2 years
    enhanced_encryption
    Safety Issue:
    No
  • Physician decision determinants of prophylaxis regimen
    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
    date_rangeTime Frame:
    At baseline
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline to one year and two years in treatment satisfaction (Hemo-SAT)
    Hemo-SAT - Hemophilia treatment satisfaction questionnaire
    date_rangeTime Frame:
    At baseline, 1 year and end of observational period, up to 2 years
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline to six months, one year and two years in Validated Hemophilia Regimen Treatment Adherence Scale-Prophylaxis (VERITAS-PRO)
    VERITAS - Validated Hemophilia Regimen Treatment Adherence Scale-Prophylaxis
    date_rangeTime Frame:
    At baseline, 6 months and end of observational period, up to 2 years
    enhanced_encryption
    Safety Issue:
    No
  • Incidence of adverse events (AEs) and serious adverse events (SAEs)
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Type of data relating to KOVALTRY PK
    Pharmacokinectic (PK) parameters - Area under the curve (AUC) - Clearance (Cl) - Half-life - FVIII trough - FVIII peak levels - In-vivo recovery
    date_rangeTime Frame:
    At routine visits, up to 2 years
    enhanced_encryption
    Safety Issue:
    No
  • The total annualized factor consumption (injections)
    date_rangeTime Frame:
    Up to 2 years
  • Change in prophylaxis dosing frequency (study start to end of observation period)
    date_rangeTime Frame:
    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)
    date_rangeTime Frame:
    At baseline and end of observation period, up to 2 years
  • Number of KOVALTRY PK assessments performed
    date_rangeTime Frame:
    At routine visits, up to 2 years
    enhanced_encryption
    Safety Issue:
    No

Trial design

A Multinational Phase IV Study Evaluating “Real World” Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog alfa) for Routine Prophylaxis
Trial Type
Observational
Intervention Type
Biological/Vaccine
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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