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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01949792
First Posted: September 25, 2013
Last Update Posted: November 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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.

Condition Intervention Phase
Congenital Bleeding Disorder Haemophilia A Haemophilia A With Inhibitors Haemophilia B Haemophilia B With Inhibitors Drug: eptacog alfa (activated) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Thromboelastography (TEG) parameter Maximum Thrombosis Generation (MTG;'maximum velocity') [ Time Frame: 10 minutes post-dose for 270 microg/kg and 10 minutes after the first injection of 90 microg/kg ]

Secondary Outcome Measures:
  • TEG parameters r-time, MTG, alpha angle, and maximum amplitude (MA) [ Time Frame: Prior to and 24 hours following the administrtion of 270 microg/kg and each of the 3 administrations of 90 microg/kg ]

Enrollment: 6
Study Start Date: September 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
Drug: eptacog alfa (activated)
Subject will receive a single injection (i.v.) of 270 microg/kg rFVIIa (NovoSeven®)
Active Comparator: 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
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)

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01949792


Locations
Spain
Madrid, Spain, 28046
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01949792     History of Changes
Other Study ID Numbers: NN7777-4086
2013-000040-26 ( EudraCT Number )
U1111-1138-2521 ( Other Identifier: WHO )
First Submitted: September 13, 2013
First Posted: September 25, 2013
Last Update Posted: November 14, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Vascular Diseases
Cardiovascular Diseases
Factor VIII
Coagulants