Clot formation and clot stability in severe haemophilia A - effect of recombinant factor VIII and tranexamic acid.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005103-41-DK

Enrollment

Registered

2005-11-10

Start date

2005-12-05

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe haemophilia A

Interventions

Trade Name: Cyklokapron Product Name: Tranexamic acid Pharmaceutical Form: Intravenous infusion Trade Name: ReFacto Product Name: Recombinant factor VIII Pharmaceutical Form: Intravenous infusion Tr

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Patients above 18 years old Severe haemophilia A Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients with inhibitory antibodies against factor VIII Renal insufficiency HIV-positive patients Allergy against tranexamic acid

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the effect of recombinant factor VIII and tranexamic acid on whole blood clot formation and whole blood clot stability.;Secondary Objective: ;Primary end point(s): Increased clot stability after infusion of factor VIII and tranexamic acid	—

Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026