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

Congenital Bleeding Disorder Clinical Trial

Official title:

An Open-label Single- and Multiple-dose Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa Following i.v. Administration of One Dose of 270 Microg/kg and Three Doses of 90 Microg/kg in Patients With Haemophilia A or B With or Without Inhibitors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01949792
• Other study ID #: NN7777-4086
• Secondary ID: 2013-000040-26U1
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2013
• Last updated: November 13, 2014
• Start date: September 2013
• Est. completion date: November 2013

Study information

• Verified date: November 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Congenital Bleeding Disorder
• Haemophilia A
• Haemophilia A With Inhibitors
• Haemophilia B
• Haemophilia B With Inhibitors
• Hemophilia A
• Hemophilia B
• Hemostatic Disorders

Intervention

Drug:
• eptacog alfa (activated)
Subject will receive a single injection (i.v.) of 270 microg/kg rFVIIa (NovoSeven®)
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

External Links

•   Clinical Trials at Novo Nordisk