Healthy VolunteersPhase 1/2NCT05205863
Dose-Response in PD and Safety of Cofact Under VKA Anticoagulation
A Phase 1/2 study testing Cofact in people with Healthy Volunteers, run by Prothya Biosolutions at 1 site in Netherlands.
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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Cofact
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Nov 2021to 3 Sep 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female of nonchildbearing potential.
- Healthy subjects.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- Cofact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CofactBiological
Human prothrombin complex concentrate
| Study group | Role | What they receive |
|---|---|---|
| Cofact Dose 1 | Experimental | Not described Receives: Biological: Cofact |
| Cofact Dose 2 | Experimental | Not described Receives: Biological: Cofact |
| Placebo | Placebo comparator | Not described Receives: Biological: Cofact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak thrombin generation at 30 minutes after end of the Cofact infusion
Measured: 30 minutes post Cofact infusion
Secondary outcomes (5)
Changes in ETP
Change in endogenous thrombin potential (ETP) over 24 hours after the EOI
Measured: 24 hours post Cofact infusion
Concentration in clotting factors
Changes in aPTT, PT, and INR
Measured: up to Day 15
Coagulation markers
Concentration over time of clotting factors: FII, FVII, FIX, FX, protein C, and protein S
Measured: up to Day 15
Coagulation activation markers
Concentration over time of Prothrombin fragment 1+2, D-dimer, and thrombin-antithrombin complexes (TATs)
Measured: up to Day 15
Safety outcome
Frequency and severity of adverse events (AEs)
Measured: up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start12 Nov 2021
- Primary completion20 Aug 2022
- Study completion3 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prothya Biosolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
- Investigators
- Salah Hadi, MD, Principal investigator, PRA Health SciencesThomas Bodewes, MD, Study chair, Prothya Biosolutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205863
- Sponsor's protocol ID
- MD2021.01
- Status last verified
- Apr 2024
- First submitted
- 23 Dec 2021
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05205863
- Acronym / sponsor ID
- MD2021.01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Prothya BiosolutionsIndustry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 3 Sep 2022 (actual)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cofact Dose 1 | Experimental | Biological: Cofact |
| Cofact Dose 2 | Experimental | Biological: Cofact |
| Placebo | Placebo comparator | Biological: Cofact |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male or female of nonchildbearing potential.
- Healthy subjects.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CofactHuman prothrombin complex concentrate | Biological | Cofact Dose 1, Cofact Dose 2, Placebo |
Primary outcome
Peak thrombin generation at 30 minutes after end of the Cofact infusion
Time frame: 30 minutes post Cofact infusion
5 secondary outcomes
Changes in ETP
Time frame: 24 hours post Cofact infusion
Concentration in clotting factors
Time frame: up to Day 15
Coagulation markers
Time frame: up to Day 15
Coagulation activation markers
Time frame: up to Day 15
Safety outcome
Time frame: up to Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salah Hadi, MD principal investigator
PRA Health Sciences
Thomas Bodewes, MD study chair
Prothya Biosolutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cofact in people with Healthy Volunteers, run by Prothya Biosolutions at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak thrombin generation at 30 minutes after end of the Cofact infusion (time frame: 30 minutes post Cofact infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.