Prediction of the Efficacy of Activated Recombinant Human Factor VII in Adult Congenital Haemophilia A or B Patients With Inhibitors by Use of Thromboelastography

An Exploratory Non-interventional Study of Ex-vivo Spiking Followed by Thromboelastography as a Method for Predicting the Efficacy of Recombinant Activated Human FVII (rFVIIa, NovoSeven®) in Adult Congenital Haemophilia A or B Patients With Inhibitors

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01561924

Enrollment

Registered

2012-03-23

Start date

2005-11-30

Completion date

2006-05-31

Last updated

2016-11-23

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

Conditions

Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors

Brief summary

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the basal and spiked TEG® (Thromboelastography) or ROTEM® (Thromboelastometry) profiles of frequently bleeding haemophilia subjects with inhibitors in a non-bleeding state.

Detailed description

The TEG parameters are: R time (Reaction Time), K time (K Time (arbitrary measurement)), a (a angle), MA (Maximum Amplitude) and LY30 (Lysis 30 min after MA) while the ROTEM parameters are: CT (Clotting Time), CFT (Clot Formation Time), a (a angle), MCF (Maximum Clot Firmness) and LI60 (Lysis index 60 min after CT)

Interventions

DRUGeptacog alfa (activated)

Subjects will be called to attend the clinic in a non-bleeding state. Blood samples will be drawn for thromboelastogram profiling and will be in-vitro spiked with different doses of activatated recombinant human factor VII.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

* Confirmed diagnosis of congenital haemophilia A or B with a FVIII:C clot activity or FIX:C clot activity, respectively, less than 5% * Presently use of activated recombinant human factor VII (NovoSeven®) as haemostatic agent for preventive treatment or treatment of bleeding episodes * A documented historical or present record for the presence of inhibitors to factor VIII or IX, respectively * A documented history of 2 or more joint bleeding episodes during the preceding 12 months * Subjects must be in a non-bleeding state (i.e. no clinical manifestations of active bleeds)

Exclusion criteria

* Subjects who have received any haemostatic treatment for a bleeding episode within the last 7 days prior to this trial * Immune tolerance therapy within the last 30 days prior to this trial * Clinically relevant coagulation disorders other than congenital haemophilia A or B * Thrombocytopenia (platelet count below 60,000 platelets/mcl) * Prophylactic haemostatic treatment within 3 days prior to this trial

Design outcomes

Primary

Measure	Time frame
TEG parameters obtained at baseline and with activated recombinant human factor VII	—
ROTEM parameters obtained at baseline and with activated recombinant human factor VII	—

Countries

Denmark, France, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026