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.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00922792
First received: June 16, 2009
Last updated: July 4, 2012
Last verified: November 2011
  Purpose

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
Endpoint Classification: Safety Study
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 ] [ Designated as safety issue: Yes ]
  • Frequency of serious adverse events [ Time Frame: after 1, 2 and 6-10 weeks after dosing ] [ Designated as safety issue: Yes ]
  • Frequency of MESIs (Medical Event of Special Interest) [ Time Frame: after 1, 2 and 6-10 weeks after dosing ] [ Designated as safety issue: Yes ]
  • Frequency of ocurrence of neutralising antibodies against FVII and/or LA-rFVIIa [ Time Frame: after 2 and 6-10 weeks after dosing ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00922792

Locations
Spain
Madrid, Spain, 28046
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Camilla Stenmo, MSc Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00922792     History of Changes
Other Study ID Numbers: NN7128-3700, 2009-010080-16
Study First Received: June 16, 2009
Last Updated: July 4, 2012
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemophilia B
Hemophilia A
Hemorrhage
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Pathologic Processes
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014