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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-04-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Congenital Bleeding Disorder Haemophilia A Haemophilia B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low dose

Group Type EXPERIMENTAL

activated recombinant human factor VII

Intervention Type DRUG

Administered as a single dose. Injected as a slow intravenous injection over 2 minutes (from start to completion of injection)

Medium dose

Group Type EXPERIMENTAL

activated recombinant human factor VII

Intervention Type DRUG

Administered as a single dose. Injected as a slow intravenous injection over 2 minutes (from start to completion of injection)

High dose

Group Type EXPERIMENTAL

activated recombinant human factor VII

Intervention Type DRUG

Administered as a single dose. Injected as a slow intravenous injection over 2 minutes (from start to completion of injection)

Interventions

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activated recombinant human factor VII

Administered as a single dose. Injected as a slow intravenous injection over 2 minutes (from start to completion of injection)

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

16 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No