Dose-Response in PD and Safety of Cofact Under VKA Anticoagulation

Healthy Volunteers Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05205863
• Other study ID #: MD2021.01
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 12, 2021
• Est. completion date: September 3, 2022

Study information

• Verified date: April 2024
• Source: Prothya Biosolutions
• Contact: n/a
• Is FDA regulated: No
• 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.

Related Conditions & MeSH terms

• Healthy Volunteers

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