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



Status:Recruiting
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:Any
Updated:3/27/2019
Start Date:October 14, 2016
End Date:June 30, 2022
Contact:Bayer Clinical Trials Contact
Email:clinical-trials-contact@bayer.com
Phone:(+) 1-888-8422937

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

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.

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

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
We found this trial at
14
sites
5153 North 9th Avenue
Pensacola, Florida 32504
(850) 505-4700
Nemours Children's Clinic - Pensacola Nemours Children’s Clinic, Pensacola serves children and families in northwest...
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936 Delaware Avenue
Buffalo, New York 14209
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2799 West Grand Boulevard
Detroit, Michigan 48202
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Gainesville, Florida 32610
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8739 West Watertown Plank Road
Milwaukee, Wisconsin 53226
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1610 Center Street
Mobile, Alabama 36604
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1304 North Wood Street
Multiple Locations, 60622
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Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Winston-Salem, North Carolina 26157
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