Trials / Completed
CompletedNCT05205863
Dose-Response in PD and Safety of Cofact Under VKA Anticoagulation
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.
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 69 (actual)
- Sponsor
- Prothya Biosolutions · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Cofact | Human prothrombin complex concentrate |
Timeline
- Start date
- 2021-11-12
- Primary completion
- 2022-08-20
- Completion
- 2022-09-03
- First posted
- 2022-01-25
- Last updated
- 2024-04-08
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT05205863. Inclusion in this directory is not an endorsement.