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Completed

NCT Number: NCT00571584

High Dose of Activated Recombinant Human Factor VII for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of two dose schedules of activated recombinant human factor VII in treatment of joint bleeds in haemophilia patients with inhibitors.

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Key information

Conditions

Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site, Le Kremlin-Bicêtre, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed of congenital haemophilia A or B with inhibitors to factor VIII or IX, respectively
  • A history of 3 or more joint bleeds during the last 12 months

Exclusion criteria

  • Joint bleeding within 7 days prior to trial start
  • Treatment for bleeds within the last 5 days prior to trial start
  • Clinically relevant coagulation disorders other than congenital haemophilia A or B

Treatment and study plan

activated recombinant human factor VII

Drug

Primary outcomes

  1. Global treatment response of the patient by an algorithm based pain and joint mobility assessments

Secondary outcomes

  1. Pain assessment

  2. Mobility assessment

  3. Circumference of joint

  4. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

rFVIIa (NovoSeven®) for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors: A Double-blind Study of a Single High Dose Versus Standard Multiple Doses of rFVIIa

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Dec 12, 2007
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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