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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Haemophilia B With Inhibitors; Haemophilia B; Haemophilia A With Inhibitors; Haemophilia A; Congenital Bleeding Disorder

Treatments: Drug: eptacog alfa (activated)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01949792

2013-000040-26 (EudraCT Number)

U1111-1138-2521 (Other Identifier)

NN7777-4086

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

270 microg/kg rFVIIa

Active Comparator group

Description:

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

Treatment:

Drug: eptacog alfa (activated)

Drug: eptacog alfa (activated)

3x90 microg/kg rFVIIa

Active Comparator group

Description:

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

Treatment:

Drug: eptacog alfa (activated)

Drug: eptacog alfa (activated)