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Completed

NCT Number: NCT01234545

Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors

This trial is conducted in Africa and Asia. The aim of this study is to evaluate the efficacy of home treatment of joint bleeds (haemarthrosis) with NovoSeven® (activated recombinant human factor VII) in patients with haemophilia A and B patients with inhibitors.

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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

2 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Algiers, Algeria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with congenital haemophilia and inhibitors to factor VIII or IX
  • Indication of activated recombinant human factor VII for the treatment of joint bleeding located in elbow, shoulder, wrist, hip, knee, ankle

Exclusion criteria

  • Known or suspected allergy to study product(s) or related products
  • Clinically relevant coagulation disorders other than congenital haemophilia A or B

Treatment and study plan

activated recombinant human factor VII

Drug

Prescription is done at the discretion of the prescribing physician as part of normal clinical routine

Primary outcomes

  1. Number of bleeds managed at home

    Time frame: Month 8

  2. Number of treatments resulting in the control of bleeding episode

    Time frame: within 9 hours after the first injection of study product

  3. Number of treatments resulting in effective pain relief

    Time frame: within 9 hours after the first injection of study product

Secondary outcomes

  1. Proportion of patient/caregivers with no need of any intervention from the physician to treat the bleeding episode at home

    Time frame: Month 8

  2. Proportion of patients who used their entire treatment at home

    Time frame: Month 8

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Prospective Observational Study on the Home Treatment of Haemarthrosis With rFVIIa (Activated Recombinant Factor VII) in Haemophilia A and B Patients With Inhibitors

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 4, 2010
Registry last updated
Nov 14, 2014

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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