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

January 11, 2017 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Kremlin-Bicêtre, France, 94270
        • Novo Nordisk Investigational Site
      • Lille, France, 59037
        • Novo Nordisk Investigational Site
      • Lyon, France, 69003
        • Novo Nordisk Investigational Site
      • Paris, France, 75015
        • Novo Nordisk Investigational Site
      • Paris, France, 75014
        • Novo Nordisk Investigational Site
  • Hungary
      • Budapest, Hungary, 1135
        • Novo Nordisk Investigational Site
  • Israel
      • Tel-Hashomer, Israel, 52621
        • Novo Nordisk Investigational Site
  • Poland
      • Poznan, Poland, 61-833
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 00-576
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 00-791
        • Novo Nordisk Investigational Site
      • Wroclaw, Poland, 50-345
        • Novo Nordisk Investigational Site
  • Spain
      • Madrid, Spain, 28046
        • Novo Nordisk Investigational Site
      • Valencia, Spain, 46026
        • Novo Nordisk Investigational Site
  • Turkey
      • Bornova-IZMIR, Turkey, 35100
        • Novo Nordisk Investigational Site
      • Capa-ISTANBUL, Turkey, 35100
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Novo Nordisk Investigational Site
      • Canterbury, United Kingdom
        • Novo Nordisk Investigational Site
      • Sheffield, United Kingdom, S10 2JF
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Global treatment response of the patient by an algorithm based pain and joint mobility assessments

Secondary Outcome Measures

Outcome Measure
Adverse events
Pain assessment
Mobility assessment
Circumference of joint

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Primary Completion (ACTUAL)

March 1, 2004

Study Completion (ACTUAL)

March 1, 2004

Study Registration Dates

First Submitted

December 11, 2007

First Submitted That Met QC Criteria

December 11, 2007

First Posted (ESTIMATE)

December 12, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F7HEAM-1510

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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