Safety and Mode of Action of a Single Dose and Multiple Doses of Long Acting Activated Recombinant Human Factor VII in Patients With Haemophilia A and B

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

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-09-30

Brief Summary

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This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and pharmacokinetics (the effect of the body on the investigated drug) of long acting activated recombinant human factor VII (LA-rFVIIa) in patients with haemophilia.

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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

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

activated recombinant human factor VII, long acting

Intervention Type DRUG

Single dose of 0,2 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration

B

Group Type EXPERIMENTAL

activated recombinant human factor VII, long acting

Intervention Type DRUG

Multiple doses of 100 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration every 48 hours

Interventions

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activated recombinant human factor VII, long acting

Single dose of 0,2 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration

Intervention Type DRUG

activated recombinant human factor VII, long acting

Multiple doses of 100 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration every 48 hours

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Haemophilia A or B
* Bodyweight max 100 kg
* Body Mass Index (BMI) max 30 kg/m2
* Adequate venous access

Exclusion Criteria

* Known or suspected allergy to trial product(s) or related products (including NovoSeven®)
* The receipt of any investigational product within 30 days prior to enrolment in this trial
* Receipt of Immune Tolerance Induction (ITI) within the last 1 month prior to participation in this trial
* The receipt of any haemostatic treatment for control of a bleeding episode within the last 5 days prior to administration of trial product
* Receipt of FVIII or FIX replacement therapy within 48 hours prior to trial product administration
* Known pseudo tumours
* Congenital or acquired coagulation disorders other than haemophilia A or B
* Any major and/or orthopaedic surgery within one month prior to trial start
* Advanced atherosclerotic disease (defined as known history of ischemic heart disease, ischemic stroke, etc.)
* Clinical signs of renal dysfunction
* Use of platelet inhibitors, including NSAIDs, one week prior to administration of trial drug
* Use of non-prescribed opiate substances

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No