This study has been transitioned to CTIS with ID 2024-514339-87-00 check the CTIS register for the current data. Primary:• To assess the effects of VMX-C001 and a DOAC on the anticoagulant effect of unfractionated heparin in healthy subjects.…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
PD parameters of VMX-C001 and the DOAC on the anticoagulant effect of
unfractionated heparin: PT, aPTT, DRVVT, dPT, D-dimer, calibrated automated
thrombography (thrombin generation), real time activated clotting time (ACT)
recording, and DOAC concentration.
Secondary outcome
• Safety and tolerability parameters include: physical examination, AEs,
clinical laboratory values, vital signs, 12-lead electrocardiogram (ECG).
• Immunogenicity: antibodies against VMX-C001 and human coagulation FX in
plasma.
Background summary
VarmX is developing an analogue of FXa, VMX-C001 that is insensitive to the
effects or FXa inhibitors, or direct oral anticoagulants (FXaDOACs). It is be
used to restore coagulation in patients taking DOACs who are experiencing
bleeding or who require reversal ofanticoagulation prior to urgent surgery.
This study is designed to simulate the clinical situation of a patient on
apixaban, edoxaban or rivaroxaban that is bleeding, requiring heparin after
reversal of the apixaban, edoxaban or rivaroxaban with VMX-C001 for ECMO,
surgery under cardiopulmonary bypass or other reasons.
Study objective
This study has been transitioned to CTIS with ID 2024-514339-87-00 check the CTIS register for the current data.
Primary:
• To assess the effects of VMX-C001 and a DOAC on the anticoagulant effect of
unfractionated heparin in healthy subjects.
Secundary:
• To assess the safety and tolerability of VMX-C001 in a simulated emergency
use setting.
• To assess the immunogenicity of VMX-C001.
Study design
Open-label study in healthy subjects
Intervention
VMX-C001 in suspension for intravenous (i.v.) infusion
Apixaban 5 mg tablets or Edoxaban 60 mg tablets or Rivaroxaban 20 mg tablets.
5000 IU/mL heparin sodium for intravenous (i.v.) infusion
Study burden and risks
Since the study is being executed in healthy volunteers, there are no
anticipated benefits of the IMP. Please see the IB for further information.
Middelweg 38 B Nap.
Leiden 2312 KJ
NL
Middelweg 38 B Nap.
Leiden 2312 KJ
NL
Listed location countries
Age
Inclusion criteria
1. Men and women of any ethnic origin aged between 18 and 49 years of age,
inclusive, at the time of Screening.
2. Male subjects must be willing to use appropriate contraception, such as a
condom, and to refrain from sperm donation during the study and until 90 days
after VMX-C001 administration.
3. Women of child-bearing potential must agree not to attempt to become
pregnant and to use a highly effective form of birth control during the study
and for 180 days after study drug administration when their sexual partner has
not been vasectomized. Highly effective forms of birth control entail the use
of combined (estrogen- and progestogen-containing) or progestogen-only hormonal
contraception associated with inhibition of ovulation, an intrauterine device
(IUD), an intrauterine hormone-releasing system (IUS) or abstinence.
4. Postmenopausal women must have had >=12 months of spontaneous amenorrhea
(with documented follicle-stimulating hormone (FSH) >=30 mIU/mL).
Exclusion criteria
1. The subject has been administered VMX-C001 before.
2. The subject has taken piroxicam in the 2 weeks prior to Day 1.
3. The subject has taken any non-aspirin, non-piroxicam NSAID in the week prior
to Day 1.
4. The subject requires or has taken during the month prior to Day 1, vitamin K
for therapeutic reasons. Vitamin K not taken for therapeutic purposes is
acceptable throughout the study, e.g. as part of a multivitamin supplement.
5. The subject is receiving or requires, for any cause, any anticoagulant or
antiplatelet therapy including warfarin, clopidogrel or aspirin or any other
anticoagulant or antiplatelet agent or has used these therapies in the month
prior to Day 1.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
Other | 2021-002215-54 |
EU-CTR | CTIS2024-514339-87-00 |
EudraCT | EUCTR2022-003675-41-NL |
CCMO | NL83154.056.22 |