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OpenTrials
Completed

NCT Number: NCT05205863

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

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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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

PRA Health Sciences

Groningen, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cofact

Biological

Human prothrombin complex concentrate

Primary outcomes

  1. Peak thrombin generation at 30 minutes after end of the Cofact infusion

    Time frame: 30 minutes post Cofact infusion

Secondary outcomes

  1. Changes in ETP

    Time frame: 24 hours post Cofact infusion

    Change in endogenous thrombin potential (ETP) over 24 hours after the EOI

  2. Concentration in clotting factors

    Time frame: up to Day 15

    Changes in aPTT, PT, and INR

  3. Coagulation markers

    Time frame: up to Day 15

    Concentration over time of clotting factors: FII, FVII, FIX, FX, protein C, and protein S

  4. Coagulation activation markers

    Time frame: up to Day 15

    Concentration over time of Prothrombin fragment 1+2, D-dimer, and thrombin-antithrombin complexes (TATs)

  5. Safety outcome

    Time frame: up to Day 15

    Frequency and severity of adverse events (AEs)

Sponsors and collaborators

Lead sponsor

Prothya Biosolutions

Industry

Collaborators

  • PRA Health Sciences

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 25, 2022
Registry last updated
Apr 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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