Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia

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

Exploratory, Multi-centre, Randomised, Double-blind, Uncontrolled Trial Evaluating the Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Secondary Bleeding Prophylaxis in Congenital Haemophilia A or B Patients With Inhibitors

This trial is conducted in Africa, Asia, Europe, South America, and the United States of America (USA).

The purpose of this study is to evaluate the effectiveness of secondary prophylactic treatment with NovoSeven® in haemophilia A and B patients with inhibitors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

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

  • Argentina
      • Ciudad Autónoma de Bs. As., Argentina, C1425ASU
        • Novo Nordisk Investigational Site
  • Brazil
      • Belo Horizonte, Brazil, 10130-110
        • Novo Nordisk Investigational Site
      • Recife, Brazil, 52011-000
        • Novo Nordisk Investigational Site
      • Ribeirao Preto, Brazil, 14051-140
        • Novo Nordisk Investigational Site
      • Rio de Janeiro, Brazil, 20211-030
        • Novo Nordisk Investigational Site
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13081970
        • Novo Nordisk Investigational Site
  • Bulgaria
      • Sofia, Bulgaria, 1756
        • Novo Nordisk Investigational Site
  • France
      • Kremlin-Bicêtre, France, 94270
        • Novo Nordisk Investigational Site
      • Lille, France, 59037
        • Novo Nordisk Investigational Site
      • Paris, France, 75015
        • Novo Nordisk Investigational Site
  • Philippines
      • Manila, Philippines
        • Novo Nordisk Investigational Site
  • Poland
      • Gdansk, Poland, 80-952
        • Novo Nordisk Investigational Site
      • Lublin, Poland, 20-954
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 00-576
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 00-791
        • Novo Nordisk Investigational Site
  • Romania
      • Bucharest, Romania, 022328
        • Novo Nordisk Investigational Site
    • Timis
      • Timisoara, Timis, Romania, 300011
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 105077
        • Novo Nordisk Investigational Site
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Novo Nordisk Investigational Site
  • Spain
      • Madrid, Spain, 28046
        • Novo Nordisk Investigational Site
      • Santander, Spain, 39008
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41013
        • Novo Nordisk Investigational Site
  • Turkey
      • Bornova-IZMIR, Turkey, 35100
        • Novo Nordisk Investigational Site
      • Capa-ISTANBUL, Turkey, 35100
        • Novo Nordisk Investigational Site
  • United States
    • California
      • Berkeley, California, United States, 94704
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90027
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Novo Nordisk Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Novo Nordisk Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Novo Nordisk Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70112-2699
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Novo Nordisk Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Novo Nordisk Investigational Site
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Novo Nordisk Investigational Site
    • New York
      • New Hyde Park, New York, United States, 11042
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19134-1095
        • Novo Nordisk Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • 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

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Diagnosis of congenital haemophilia A or B with inhibitors development against FVIII or FIX, respectively

Exclusion Criteria:

  • Prophylactic administration of any haemostatic drug within 3 last months prior to entering the trial.

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 Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of bleeds
Time Frame: During 3 months treatment period as compared to 3 months observation period
During 3 months treatment period as compared to 3 months observation period

Secondary Outcome Measures

Outcome Measure
Efficacy variables

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

March 1, 2004

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

April 18, 2005

First Submitted That Met QC Criteria

April 18, 2005

First Posted (Estimate)

April 19, 2005

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

  • F7HAEM-1505

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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