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

NCT05205863 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2024-04-08

No results posted yet for this study

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

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

Cofact

Human prothrombin complex concentrate

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Prothya Biosolutions

    lead INDUSTRY

Principal Investigators

  • Salah Hadi, MD · PRA Health Sciences

  • Thomas Bodewes, MD · Prothya Biosolutions

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-12
Primary Completion
2022-08-20
Completion
2022-09-03

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05205863 on ClinicalTrials.gov