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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05205863
Other study ID # MD2021.01
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date November 12, 2021
Est. completion date September 3, 2022

Study information

Verified date April 2023
Source Prothya Biosolutions
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date September 3, 2022
Est. primary completion date August 20, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Male or female of nonchildbearing potential. - Healthy subjects. Exclusion Criteria: - Evidence of coagulation disturbances, or disposition for thrombo-embolic events - Liver function tests more than 1.2 times the upper normal limits - Participants with thyroid disorders as evidenced by assessment of TSH levels outside the normal reference range at screening. - Prior history of thromboembolic complications including those in first degree relatives. - Glomerular filtration rate (GFR) is lower than estimated GFR 62 mL/min/1.73 m2 using the Modification of Diet in Renal Disease Study equation. - Anaphylactic or systemic reactions to human plasma, plasma products, or blood products. - History of hypersensitivity to active or inactive excipients of VKA - Gastrointestinal disease that may impair VKA absorption.. - Participation in another clinical study <30 days prior to study entry. - Any clinically significant history of or current clinically significant disease or disorder as judged by the Investigator. - Positive nasopharyngeal PCR test for SARS-CoV-2 on Day -11 or Day -1. - Positive pregnancy test at screening, Day -11, or Day -1.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Cofact
Human prothrombin complex concentrate

Locations

Country Name City State
Netherlands PRA Health Sciences Groningen

Sponsors (2)

Lead Sponsor Collaborator
Prothya Biosolutions PRA Health Sciences

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Peak thrombin generation at 30 minutes after end of the Cofact infusion 30 minutes post Cofact infusion
Secondary Changes in ETP Change in endogenous thrombin potential (ETP) over 24 hours after the EOI 24 hours post Cofact infusion
Secondary Concentration in clotting factors Changes in aPTT, PT, and INR up to Day 15
Secondary Coagulation markers Concentration over time of clotting factors: FII, FVII, FIX, FX, protein C, and protein S up to Day 15
Secondary Coagulation activation markers Concentration over time of Prothrombin fragment 1+2, D-dimer, and thrombin-antithrombin complexes (TATs) up to Day 15
Secondary Safety outcome Frequency and severity of adverse events (AEs) up to Day 15
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