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OpenTrials
Completed

NCT Number: NCT00922792

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 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.

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Key information

Conditions

Congenital Bleeding Disorder Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Haemophilia A Haemophilia B Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemophilia B Hemorrhagic Disorders

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Madrid, 28046, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

activated recombinant human factor VII, long acting

Drug

Single dose of 0,2 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration

Primary outcomes

  1. Frequency of adverse events

    Time frame: after 1 and 2 weeks after dosing

  2. Frequency of serious adverse events

    Time frame: after 1, 2 and 6-10 weeks after dosing

  3. Frequency of MESIs (Medical Event of Special Interest)

    Time frame: after 1, 2 and 6-10 weeks after dosing

  4. Frequency of ocurrence of neutralising antibodies against FVII and/or LA-rFVIIa

    Time frame: after 2 and 6-10 weeks after dosing

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 17, 2009
Registry last updated
May 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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