Version testing of EnzySystem Version A for Hemophilia A

• Conditions: congenital bleedingdisorder; Hemophilia A; 10064477

• Registration Number: NL-OMON56741
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

Healthy volunteers:
Age between 20between 20 to 70 years old (equally distributed over the age
range)
- 7 volunteers 20-40 years old
- 7 volunteers 40-60 years old
- 6 volunteers 60+ years old

Hemophilia A patients:
Diagnosed with mild (FVIII activity levels 5-40%), moderate (FVIII activity
levels 1-5%) or severe hemophilia A (FVIII activity levels <1%)
Medication
- On demand treatment
- Washout of medication of at least 24 hours after treatment with short half
life (SHL) replacement therapy
- Washout of medication of at least 72 hours after treatment with extended half
life (EHL) replacement therapy
Age 20-70 years old

Exclusion Criteria

A healthy volunteer who meets any of the following criteria will be excluded
from participation in this study:
use of anticoagulants or platelet antagonists (aspirin or any TAR);
known allergy to stainless steel;
trauma or surgery within the last two weeks;
pregnancy;
use of:
- NSAIDs;
- antimicrobial medication;
- thyroid inhibitors; or SSRI*s.

A hemophilia A patient who meets any of the following criteria will be excluded
from participation in this study:
use of anticoagulants or platelet antagonists (aspirin or any TAR);
known allergy to stainless steel;
trauma or surgery within the last two weeks;
a bleeding episode within the last two weeks;
clinical indication of liver cirrhosis (echographic indication, enlarged
spleen, decreased platelet count);
pregnancy;
acquired FVIII inhibitors;
use of:
- NSAIDs;
- antimicrobial medication;
- thyroid inhibitors or SSRI*s;
- Emicizumab.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Demonstrate that the EnzySystem HemA version A can record TG and quantitative<br /><br>FVIII activity levels within a time frame of 60 min in fresh blood samples of<br /><br>healthy volunteers and patients with hemophilia A. </p><br>