Intra-subject Variability Following Administrations of Activated Recombinant Human Factor VII in Haemophilia Patients in a Non-bleeding State

Phase 1

Completed

• Conditions: Haemophilia A; Haemophilia B; Congenital Bleeding Disorder
• Interventions: Drug: activated recombinant human factor VII

• Registration Number: NCT01562457
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Asia and Europe. The aim of this trial is to evaluate the intra-subject variability of thromboelastographic parameters (TEG® and ROTEM®) following two administrations of activated recombinant human factor VII in haemophilia patients in a non bleeding state.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-03-22
• Study First Posted: 2012-03-23
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• Confirmed diagnosis of congenital haemophilia A or B with a FVIII:C (Activated Coagulation Factor VIIa Clotting activity) or FIX:C (Coagulation Factor IX Clotting activity) one stage activity, respectively, at less than 5% of normal (based on medical records) plus/minus inhibitors (a positive inhibitor status defined as 0.6 Bethesda units)
• Non-bleeding state (i.e. no clinical manifestation of active bleed) at the time of administration of trial product

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Exclusion Criteria

• Known or suspected allergy to trial product or any of its components or to related products
• Known clinically relevant coagulation disorders or insufficiencies other than congenital haemophilia A or B
• Platelet count below 50,000 platelets/mcL
• Received any haemostatic treatment (e.g. Feiba) within the last 7 days prior to administration of trial product, except for activated recombinant human factor VII

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose	activated recombinant human factor VII	-
Medium dose	activated recombinant human factor VII	-
High dose	activated recombinant human factor VII	-

Primary Outcome Measures

Name	Time	Method
TEG® (Thromboelastography) parameters after dosing of trial product
ROTEM® (Thromboelastometry) parameters after dosing of trial product

Secondary Outcome Measures

Name	Time	Method
TEG® parameters obtained from blood samples spiked ex vivo with activated recombinant human factor VII
ROTEM® parameters obtained from blood samples spiked ex vivo with activated recombinant human factor VII
Serious adverse events and non-serious adverse events