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Safety and Mode of Action of a Single Dose and Multiple Doses of Long Acting Activated Recombinant Human Factor VII in Patients With Haemophilia A and B

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: June 16, 2009
Last updated: May 12, 2016
Last verified: May 2016
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and pharmacokinetics (the effect of the body on the investigated drug) of long acting activated recombinant human factor VII (LA-rFVIIa) in patients with haemophilia.

Condition Intervention Phase
Congenital Bleeding Disorder
Haemophilia A
Haemophilia B
Drug: activated recombinant human factor VII, long acting
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open, Non-Randomised Single and Multiple Dose Trial Investigating the Safety and Pharmacokinetics of Intravenous Administration of Long Acting rFVIIa (LA-rFVIIa) in Patients With Haemophilia A and B

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Frequency of adverse events [ Time Frame: after 1 and 2 weeks after dosing ]
  • Frequency of serious adverse events [ Time Frame: after 1, 2 and 6-10 weeks after dosing ]
  • Frequency of MESIs (Medical Event of Special Interest) [ Time Frame: after 1, 2 and 6-10 weeks after dosing ]
  • Frequency of ocurrence of neutralising antibodies against FVII and/or LA-rFVIIa [ Time Frame: after 2 and 6-10 weeks after dosing ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters based on FVIIa activity. The pharmacokinetic parameters to be reported are: AUC(0-48h), AUC(0-t) and AUC, C10min, Vz, CL, and t½ [ Time Frame: from time of dosing up to 72 hours after the last dose ]

Enrollment: 8
Study Start Date: June 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: activated recombinant human factor VII, long acting
Single dose of 0,2 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration
Experimental: B Drug: activated recombinant human factor VII, long acting
Multiple doses of 100 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration every 48 hours


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Haemophilia A or B
  • Bodyweight max 100 kg
  • Body Mass Index (BMI) max 30 kg/m2
  • Adequate venous access

Exclusion Criteria:

  • Known or suspected allergy to trial product(s) or related products (including NovoSeven®)
  • The receipt of any investigational product within 30 days prior to enrolment in this trial
  • Receipt of Immune Tolerance Induction (ITI) within the last 1 month prior to participation in this trial
  • The receipt of any haemostatic treatment for control of a bleeding episode within the last 5 days prior to administration of trial product
  • Receipt of FVIII or FIX replacement therapy within 48 hours prior to trial product administration
  • Known pseudo tumours
  • Congenital or acquired coagulation disorders other than haemophilia A or B
  • Any major and/or orthopaedic surgery within one month prior to trial start
  • Advanced atherosclerotic disease (defined as known history of ischemic heart disease, ischemic stroke, etc.)
  • Clinical signs of renal dysfunction
  • Use of platelet inhibitors, including NSAIDs, one week prior to administration of trial drug
  • Use of non-prescribed opiate substances
  Contacts and Locations
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Please refer to this study by its identifier: NCT00922792

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

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00922792     History of Changes
Other Study ID Numbers: NN7128-3700
2009-010080-16 ( EudraCT Number )
Study First Received: June 16, 2009
Last Updated: May 12, 2016

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders
Hemostatic Disorders
Hemophilia B
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Vascular Diseases
Cardiovascular Diseases
Genetic Diseases, X-Linked
Factor VIII
Coagulants processed this record on May 24, 2017