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Completed

NCT Number: NCT01562587

Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non- Bleeding State

This trial is conducted in Europe. The aim of this trial is to determine the pharmacokinetics of activated recombinant human factor VII (NovoSeven®) in haemophiliac patients in a non-bleeding state.

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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

3 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site, Bremen, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-55 years and congenital haemophilia A or B male with severe FVIII or FX deficiency +/-inhibitors
  • Age between 3-12 years and congenital haemophilia A or B male with record of inhibitors

Exclusion criteria

  • Known hypersensitivity to activated recombinant human factor VII or any of its components
  • Known clinical relevant coagulation diseases or insufficiencies other than congenital haemophilia
  • Clinical manifestation of HIV (human immunodeficiency virus) and/or protease inhibitor treatment
  • Clinical manifestation of active/recent bleeding
  • Administration of coagulation factor preparations within 24 hours of NovoSeven trial product dose administration
  • Body Mass Index (BMI) outside normal range
  • Known abuse of elicit drugs and/or alcohol
  • Renal insufficiency
  • Hepatic disease
  • Cardiovascular disease
  • Any disease or condition which, judged by the Investigator, could imply a potential hazard to the patient, interfere with the trial participation or trial outcome

Treatment and study plan

activated recombinant human factor VII

Drug

A single bolus dose is administered. Injected intravenously

Primary outcomes

  1. Area under the concentration curve from 0-12 hours

Secondary outcomes

  1. CL, the total body clearance

  2. Cmax, the maximum concentration

  3. tmax, the time to maximum concentration

  4. t1/2, the terminal half-life

  5. Area under the concentration curve from time 0-infinity

  6. Vss, the apparent volume of distribution at steady state

  7. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non-Bleeding State

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Mar 26, 2012
Registry last updated
Jan 12, 2017

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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