Trial Condition(s):
Hemophilia A, Congenital
Study Evaluating “Real World” Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog alfa) for Routine Prophylaxis (TAURUS)
Bayer Identifier:
18559
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site many locations, Germany | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site many locations, France | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site many locations, Italy | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site many locations, Belgium | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site many locations, Netherlands | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site many locations, Spain | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site many locations, Greece | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site many locations, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site many locations, Taiwan, China | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Wake Forest University School of Medicine Winston-Salem, United States | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Washington University Center for Bleeding and Blood Clotting Disorders St. Louis, United States | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Colorado Hemophilia and Thrombosis Center Aurora, United States | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hemophilia Center of Western New York Buffalo, United States | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Children’s Rehabilitation Services/ University of South Alabama Mobile, United States | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Nemours Children’s Clinic – Division of Pediatric Hematology/Oncology – Jacksonsville Jacksonville, United States | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Nemours Children’s Clinic – Pensacola Pensacola, United States | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Comprehensive Center for Bleeding Disorders / Blood Center of Wisconsin Milwaukee, United States | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Children’s Hospital at OU Medical Center Oklahoma, United States | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Henry Ford Hospital Adult Hemophilia and Thrombosis Treatment Center Detroit, United States | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Florida Health Cancer Center Gainesville, United States | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Intermountain Hemophilia & Thrombosis Center Salt Lake City, United States | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations East Carolina University – Brody School of Medicine Greenville, United States | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site many locations, Canada | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site many locations, Luxembourg | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site many locations, Slovenia | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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:
1
Primary Outcome
- Proportion of patients on 2x and 3x weekly prophylaxis at end of observation periodTimeframe: Up to 2 years
Secondary Outcome
- Annualized composite number of reported bleeds (total, spontaneous, joint and trauma)Timeframe: Up to 2 years
- Proportion of patients in predefined prophylaxis regimen per age group and per countryAge 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 dayTimeframe: At the end of observational period, up to 2 years
- Physician decision determinants of prophylaxis regimenAge 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 OtherTimeframe: At baseline
- Change from baseline to one year and two years in treatment satisfaction (Hemo-SAT)Hemo-SAT - Hemophilia treatment satisfaction questionnaireTimeframe: 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)VERITAS - Validated Hemophilia Regimen Treatment Adherence Scale-ProphylaxisTimeframe: At baseline, 6 months and end of observational period, up to 2 years
- Incidence of adverse events (AEs) and serious adverse events (SAEs)Timeframe: Up to 2 years
- Type of data relating to KOVALTRY PKPharmacokinectic (PK) parameters - Area under the curve (AUC) - Clearance (Cl) - Half-life - FVIII trough - FVIII peak levels - In-vivo recoveryTimeframe: At routine visits, up to 2 years
- The total annualized factor consumption (injections)Timeframe: Up to 2 years
- Change in prophylaxis dosing frequency (study start to end of observation period)Timeframe: 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)Timeframe: At baseline and end of observation period, up to 2 years
- Number of KOVALTRY PK assessments performedTimeframe: At routine visits, up to 2 years
Additional Information
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