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 |
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.
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.
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
8739 West Watertown Plank Road
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
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Nemours Children's Clinic - Pensacola Nemours Children’s Clinic, Pensacola serves children and families in northwest...
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2799 West Grand Boulevard
Detroit, Michigan 48202
Detroit, Michigan 48202
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807 Childrens Way
Jacksonville, Florida 32207
Jacksonville, Florida 32207
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1610 Center Street
Mobile, Alabama 36604
Mobile, Alabama 36604
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