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

Hemophilia A, Congenital Clinical Trial

— TAURUS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02830477
• Other study ID #: 18559
• Secondary ID: KV1601
• Status: Completed
• Start date: October 14, 2016
• Est. completion date: March 1, 2021

Study information

• Verified date: November 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Open label, prospective, non-interventional, single arm study in patients receiving KOVALTRY as prophylaxis therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 313
• Est. completion date: March 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hemophilia A
• Hemophilia A, Congenital

Intervention

Biological:
• Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973
unmodified, full length recombinant FVIII

Locations

Country	Name	City	State
United States	University of Colorado Hemophilia and Thrombosis Center	Aurora	Colorado
United States	Hemophilia Center of Western New York	Buffalo	New York
United States	Henry Ford Hospital Adult Hemophilia and Thrombosis Treatment Center	Detroit	Michigan
United States	University of Florida Health Cancer Center	Gainesville	Florida
United States	East Carolina University - Brody School of Medicine	Greenville	North Carolina
United States	Nemours Children's Clinic - Division of Pediatric Hematology/Oncology - Jacksonsville	Jacksonville	Florida
United States	Comprehensive Center for Bleeding Disorders / Blood Center of Wisconsin	Milwaukee	Wisconsin
United States	Children's Rehabilitation Services/ University of South Alabama	Mobile	Alabama
United States	Children's Hospital at OU Medical Center	Oklahoma City	Oklahoma
United States	Nemours Children's Clinic - Pensacola	Pensacola	Florida
United States	Washington University Center for Bleeding and Blood Clotting Disorders	Saint Louis	Missouri
United States	Intermountain Hemophilia & Thrombosis Center	Salt Lake City	Utah
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Colombia,  France,  Germany,  Greece,  Italy,  Luxembourg,  Netherlands,  Slovenia,  Spain,  Taiwan, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients on 2x and 3x weekly prophylaxis at end of observation period		Up to 2 years
Secondary	Annualized composite number of reported bleeds (total, spontaneous, joint and trauma)		Up to 2 years
Secondary	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	At the end of observational period, up to 2 years
Secondary	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	At baseline
Secondary	Change from baseline to one year and two years in treatment satisfaction (Hemo-SAT)	Hemo-SAT - Hemophilia treatment satisfaction questionnaire	At baseline, 1 year and end of observational period, up to 2 years
Secondary	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	At baseline, 6 months and end of observational period, up to 2 years
Secondary	Incidence of adverse events (AEs) and serious adverse events (SAEs)		Up to 2 years
Secondary	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	At routine visits, up to 2 years
Secondary	The total annualized factor consumption (injections)		Up to 2 years
Secondary	Change in prophylaxis dosing frequency (study start to end of observation period)		At baseline and end of observation period, up to 2 years
Secondary	Reasons for selection of initial dose / dosing frequency of Kovaltry (study start to end of observation period)		At baseline and end of observation period, up to 2 years
Secondary	Number of KOVALTRY PK assessments performed		At routine visits, up to 2 years

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