PRA Health Sciences
Groningen, Netherlands
NCT Number: NCT05205863
This is a randomized, open label, placebo-controlled, parallel design, single center, prospective study. Subjects will receive treatment with VKA. Subjects who reach the targeted INR, will receive single dose of Cofact. Multiple coagulation laboratory tests will be evaluated over a period of 15 days
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1 / Phase 2
Groningen, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Human prothrombin complex concentrate
Time frame: 30 minutes post Cofact infusion
Time frame: 24 hours post Cofact infusion
Change in endogenous thrombin potential (ETP) over 24 hours after the EOI
Time frame: up to Day 15
Changes in aPTT, PT, and INR
Time frame: up to Day 15
Concentration over time of clotting factors: FII, FVII, FIX, FX, protein C, and protein S
Time frame: up to Day 15
Concentration over time of Prothrombin fragment 1+2, D-dimer, and thrombin-antithrombin complexes (TATs)
Time frame: up to Day 15
Frequency and severity of adverse events (AEs)
Prothya Biosolutions
Industry
A Phase 1/2 Study of the Dose-Response in Pharmacodynamics and Safety of Prothrombin Complex Concentrate Cofact in Healthy Subjects Under Vitamin K Antagonist Anticoagulation.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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