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

Phase 1

Completed

• Conditions: Haemophilia B; Haemophilia B With Inhibitors; Haemophilia A; Congenital Bleeding Disorder; Haemophilia A With Inhibitors
• Interventions: Drug: eptacog alfa (activated)

• Registration Number: NCT01949792
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-13
• Study First Submitted QC: 2013-09-24
• Study First Posted: 2013-09-25
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-13
• Last Update Posted: 2014-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
270 microg/kg rFVIIa	eptacog alfa (activated)	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
3x90 microg/kg rFVIIa	eptacog alfa (activated)	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

Primary Outcome Measures

Name	Time	Method
Thromboelastography (TEG) parameter Maximum Thrombosis Generation (MTG;'maximum velocity')	10 minutes post-dose for 270 microg/kg and 10 minutes after the first injection of 90 microg/kg

Secondary Outcome Measures

Name	Time	Method
TEG parameters r-time, MTG, alpha angle, and maximum amplitude (MA)	Prior to and 24 hours following the administrtion of 270 microg/kg and each of the 3 administrations of 90 microg/kg