A study to investigate the safety, pharmacokinetics and pharmacodynamics of a new recombinant human factor VIIa in healthy males, compared to Novoseven.
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pharmacokinetics of FVIIa (activity and FVIIa antigen)
Pharmacodynamics of FVIIa:
- Thrombin generation assay output (AUC: primary variable);
- activated partial thromboplastin time (aPTT);
- prothrombin time (PT);
- FVIIa activity;
- anti-Xa;
- Prothrombin fragments 1+2 (F1+2);
- D-dimer;
- fibrinogen;
- antithrombin;
- thrombin antithrombin complex (TAT)
Safety:
Physical examinations, ECGs, vital signs, clinical laboratory tests, immunology
tests, and monitoring of adverse events, coagulation parameters.
Secondary outcome
see above
Background summary
Factor VIIa is a good therapeutic option to treat patients suffering from
haemophilia who have developed antibodies against factor VIII or IX.
GTC aims with this new human recombinant factor VIIA to develop a good therapy
to treat patients with haemophilia. The safety and efficacy of the new product
will be compared to those of Novoseven, a compound that is currently registerd
in Europe and the US.
Study objective
A study to investigate the safety, pharmacokinetics and pharmacodynamics of a
new recombinant human factor VIIa in healthy males, compared to Novoseven.
Study design
Parallel study, blinded, placebo-controlled. 3 cohorts with increasing doses.
Study burden and risks
The study day is intensive as a consequence of the relatively frequent blood
sampling. The insertion of a canule can be painful and result in a bruise.
There is a potential risk for disturbance of coagulation, but the risks for the
volunteers are small, and can be treated well if needed.
Zernikedreef 10
2333 CL Leiden
NL
Zernikedreef 10
2333 CL Leiden
NL
Listed location countries
Age
Inclusion criteria
Healthy male volunteers, 19-45 years of age, BMI 19-30 kg/m^2
Exclusion criteria
Bleeding or coagulation disorder, recent trauma, thromboembolic event, history of administration of any rhFVIIa product, positive reaction to rabbit allergens. See protocol for detailed list of exclusion criteria.
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 |
|---|---|
| EudraCT | EUCTR2010-022639-13-NL |
| CCMO | NL33877.058.10 |