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

NCT02830477 | Completed

• 2 other identifiers: 18559KV1601
• Study Type: observational
• Target: 313
• Locations: 13 countries
• Sites: 25

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.

Conditions

Hemophilia A, Congenital

Keywords

Previously treated patients

Outcome Measures

Primary Outcomes (1)

• Proportion of patients on 2x and 3x weekly prophylaxis at end of observation period

  Up to 2 years

Secondary Outcomes (11)

• Annualized composite number of reported bleeds (total, spontaneous, joint and trauma)

  Up to 2 years

• Proportion of patients in predefined prophylaxis regimen per age group and per country

  At the end of observational period, up to 2 years

• Physician decision determinants of prophylaxis regimen

  At baseline

• Change from baseline to one year and two years in treatment satisfaction (Hemo-SAT)

  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)

  At baseline, 6 months and end of observational period, up to 2 years

Study Arms (1)

BAY81-8973

Previously treated patients receiving IV infusion of KOVALTRY for routine prophylaxis

Biological: Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973

Interventions

Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973 BIOLOGICAL

unmodified, full length recombinant FVIII

BAY81-8973

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (25)

Children's Rehabilitation Services/ University of South Alabama

Mobile, Alabama, United States

Location

University of Colorado Hemophilia and Thrombosis Center

Aurora, Colorado, United States

Location

University of Florida Health Cancer Center

Gainesville, Florida, United States

Location

Nemours Children's Clinic - Division of Pediatric Hematology/Oncology - Jacksonsville

Jacksonville, Florida, United States

Location

Nemours Children's Clinic - Pensacola

Pensacola, Florida, United States

Location

Henry Ford Hospital Adult Hemophilia and Thrombosis Treatment Center

Detroit, Michigan, United States

Location

Washington University Center for Bleeding and Blood Clotting Disorders

St Louis, Missouri, United States

Location

Hemophilia Center of Western New York

Buffalo, New York, United States

Location

East Carolina University - Brody School of Medicine

Greenville, North Carolina, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

Location

Children's Hospital at OU Medical Center

Oklahoma City, Oklahoma, United States

Location

Intermountain Hemophilia & Thrombosis Center

Salt Lake City, Utah, United States

Location

Comprehensive Center for Bleeding Disorders / Blood Center of Wisconsin

Milwaukee, Wisconsin, United States

Location

Unknown Facility

Multiple Locations, Belgium

Location

Unknown Facility

Multiple Locations, Canada

Location

Unknown Facility

Multiple Locations, Colombia

Location

Unknown Facility

Multiple Locations, France

Location

Unknown Facility

Multiple Locations, Germany

Location

Unknown Facility

Multiple Locations, Greece

Location

Unknown Facility

Multiple Locations, Italy

Location

Unknown Facility

Multiple Locations, Luxembourg

Location

Unknown Facility

Multiple Locations, Netherlands

Location

Unknown Facility

Multiple Locations, Slovenia

Location

Unknown Facility

Multiple Locations, Spain

Location

Unknown Facility

Multiple Locations, Taiwan

Location

Related Publications (1)

• Santoro C, Fuh B, Le PQ, Maes P, Berrueco R, Mingot-Castellano EM, von Mackensen S, Tueckmantel C, Cabre-Marquez JF, Wang M. Efficacy and safety in patients with haemophilia A switching to octocog alfa (BAY 81-8973): Final results of the global real-world study, TAURUS. Eur J Haematol. 2023 Jan;110(1):77-87. doi: 10.1111/ejh.13876. Epub 2022 Oct 17.

  PMID: 36192847 RESULT

Related Links

• Click here to find results for studies related to Bayer products

MeSH Terms

Conditions

Hemophilia A

Interventions

F8 protein, human; Factor VIII

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 13, 2016
• Study Start: October 14, 2016
• Primary Completion: December 1, 2020
• Study Completion: March 1, 2021
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

ES (1); SL (1); DE (1); BE (1); CO (1); GR (1); LU (1); TW (1); NL (1); US (13); CA (1); IT (1); FR (1)