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:

NCT02830477

EudraCT Number:

Not Available

Study Completed

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
313
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

many locations, Germany

Status
Completed
 
Locations

Investigative Site

many locations, France

Status
Completed
 
Locations

Investigative Site

many locations, Italy

Status
Completed
 
Locations

Investigative Site

many locations, Belgium

Status
Completed
 
Locations

Investigative Site

many locations, Netherlands

Status
Completed
 
Locations

Investigative Site

many locations, Spain

Status
Completed
 
Locations

Investigative Site

many locations, Greece

Status
Completed
 
Locations

Investigative Site

many locations, Colombia

Status
Completed
 
Locations

Investigative Site

many locations, Taiwan, China

Status
Completed
 
Locations

Wake Forest University School of Medicine

Winston-Salem, United States

Status
Completed
 
Locations

Washington University Center for Bleeding and Blood Clotting Disorders

St. Louis, United States

Status
Completed
 
Locations

University of Colorado Hemophilia and Thrombosis Center

Aurora, United States

Status
Completed
 
Locations

Hemophilia Center of Western New York

Buffalo, United States

Status
Completed
 
Locations

Children’s Rehabilitation Services/ University of South Alabama

Mobile, United States

Status
Completed
 
Locations

Nemours Children’s Clinic – Division of Pediatric Hematology/Oncology – Jacksonsville

Jacksonville, United States

Status
Completed
 
Locations

Nemours Children’s Clinic – Pensacola

Pensacola, United States

Status
Completed
 
Locations

Comprehensive Center for Bleeding Disorders / Blood Center of Wisconsin

Milwaukee, United States

Status
Completed
 
Locations

Children’s Hospital at OU Medical Center

Oklahoma, United States

Status
Completed
 
Locations

Henry Ford Hospital Adult Hemophilia and Thrombosis Treatment Center

Detroit, United States

Status
Completed
 
Locations

University of Florida Health Cancer Center

Gainesville, United States

Status
Completed
 
Locations

Intermountain Hemophilia & Thrombosis Center

Salt Lake City, United States

Status
Completed
 
Locations

East Carolina University – Brody School of Medicine

Greenville, United States

Status
Completed
 
Locations

Investigative Site

many locations, Canada

Status
Completed
 
Locations

Investigative Site

many locations, Luxembourg

Status
Completed
 
Locations

Investigative Site

many locations, Slovenia

Status
Completed
 

Trial Design