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A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors

NCT ID: NCT01949792

Last Updated: 2014-11-14

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

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2013-11-30

Brief Summary

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This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of rFVIIa (activated coagulation factor VII) following one single injection of 270 microg/kg compared to three injections of 90 microg/kg rFVIIa in patients with haemophilia.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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270 microg/kg rFVIIa

Each subject will receive one single injection of 270 microg/kg and three injections of 90 microg/kg rFVIIa (one injection every 3 hours) in a randomised order. The two administration days will be separated by a wash-out period of at least 48 hours

Group Type ACTIVE_COMPARATOR

eptacog alfa (activated)

Intervention Type DRUG

Subject will receive a single injection (i.v.) of 270 microg/kg rFVIIa (NovoSeven®)

3x90 microg/kg rFVIIa

Each subject will receive one single injection of 270 microg/kg and three injections of 90 microg/kg rFVIIa (one injection every 3 hours) in a randomised order. The two administration days will be separated by a wash-out period of at least 48 hours

Group Type ACTIVE_COMPARATOR

eptacog alfa (activated)

Intervention Type DRUG

Subject will receive 3 injections (i.v.) of 90 microg/kg rFVIIa (NovoSeven®) over a 6 hour period (each injection will be separated by 3 hours)

Interventions

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eptacog alfa (activated)

Subject will receive a single injection (i.v.) of 270 microg/kg rFVIIa (NovoSeven®)

Intervention Type DRUG

eptacog alfa (activated)

Subject will receive 3 injections (i.v.) of 90 microg/kg rFVIIa (NovoSeven®) over a 6 hour period (each injection will be separated by 3 hours)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Male patients with confirmed diagnosis of severe congenital haemophilia A or B (higher than 1% FVIII or FIX) with or without inhibitors to coagulation factors VIII or IX, based on medical records

Exclusion Criteria

* Congenital or acquired coagulation disorder other than congenital haemophilia A or B
* Any clinical signs or known history of arterial thrombotic events or previous deep vein thrombosis or pulmonary embolism (as defined by available medical records)
* Use of any anticoagulant (e.g. un-fractionated or low molecular weight heparin, vitamin-K antagonists, direct thrombin inhibitors or factor Xa inhibitors)
* Bleeding prophylactic treatment or FVIII or FIX immune tolerance induction (ITI) treatment during the trial period
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Madrid, , Spain

Site Status

Countries

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Spain

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2013-000040-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1138-2521

Identifier Type: OTHER

Identifier Source: secondary_id

NN7777-4086

Identifier Type: -

Identifier Source: org_study_id