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

NCT05205863 | Completed Phase 1 DMC

• 1 other identifier: MD2021.01
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  30 minutes post Cofact infusion

Secondary Outcomes (5)

• Changes in ETP

  24 hours post Cofact infusion

• Concentration in clotting factors

  up to Day 15

• Coagulation markers

  up to Day 15

• Coagulation activation markers

  up to Day 15

• Safety outcome

  up to Day 15

Study Arms (3)

Cofact Dose 1

EXPERIMENTAL

Biological: Cofact

Cofact Dose 2

EXPERIMENTAL

Biological: Cofact

Placebo

PLACEBO COMPARATOR

Biological: Cofact

Interventions

Cofact BIOLOGICAL

Human prothrombin complex concentrate

Cofact Dose 1; Cofact Dose 2; Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female of nonchildbearing potential.
• Healthy subjects.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prothya Biosolutions: lead
• PRA Health Sciences: collaborator

Study Sites (1)

PRA Health Sciences

Groningen, Netherlands

Location

MeSH Terms

Interventions

prothrombin complex concentrates

Study Officials

• Salah Hadi, MD

  PRA Health Sciences

  PRINCIPAL INVESTIGATOR

• Thomas Bodewes, MD

  Prothya Biosolutions

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 25, 2022
• Study Start: November 12, 2021
• Primary Completion: August 20, 2022
• Study Completion: September 3, 2022
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)