Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children With Haemophilia A (guardian™ 3)

February 9, 2017 updated by: Novo Nordisk A/S

A Multi-Centre, Open-Label, Non-Controlled Trial on Safety and Efficacy of N8 in Previously Treated Paediatric Patients With Haemophilia A

This trial is conducted in Asia, Europe, and North and South America. The aim of this clinical trial is to investigate the safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in male previously treated paediatric subjects with haemophilia A.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 3

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

  • Brazil
      • Rio de Janeiro, Brazil, 20211-030
        • Novo Nordisk Investigational Site
    • Parana
      • Curitiba, Parana, Brazil, 80250-060
        • Novo Nordisk Investigational Site
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13081970
        • Novo Nordisk Investigational Site
      • São Paulo, Sao Paulo, Brazil, 05403-000
        • Novo Nordisk Investigational Site
  • Italy
      • Milano, Italy, 20124
        • Novo Nordisk Investigational Site
  • Japan
      • Shizuoka-shi, Shizuoka, Japan, 4208660
        • Novo Nordisk Investigational Site
  • Lithuania
      • Vilnius, Lithuania, LT-08406
        • Novo Nordisk Investigational Site
  • Macedonia, The Former Yugoslav Republic of
      • Skopje, Macedonia, The Former Yugoslav Republic of, 1000
        • Novo Nordisk Investigational Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 50400
        • Novo Nordisk Investigational Site
  • Poland
      • Warszawa, Poland, 00-576
        • Novo Nordisk Investigational Site
      • Wroclaw, Poland, 50-345
        • Novo Nordisk Investigational Site
  • Puerto Rico
      • San Juan, Puerto Rico, 00935
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 105077
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 191119
        • Novo Nordisk Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Novo Nordisk Investigational Site
  • Taiwan
      • Taipei, Taiwan, 40447
        • Novo Nordisk Investigational Site
  • Turkey
      • Adana, Turkey, 01130
        • Novo Nordisk Investigational Site
      • Antalya, Turkey, 01010
        • Novo Nordisk Investigational Site
      • Bornova-IZMIR, Turkey, 35100
        • Novo Nordisk Investigational Site
      • Izmit, Turkey, 41380
        • Novo Nordisk Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016-7710
        • Novo Nordisk Investigational Site
    • California
      • Orange, California, United States, 92868
        • Novo Nordisk Investigational Site
      • Torrance, California, United States, 90502-2004
        • Novo Nordisk Investigational Site
    • Florida
      • Tampa, Florida, United States, 33607
        • Novo Nordisk Investigational Site
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Novo Nordisk Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Novo Nordisk Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Novo Nordisk Investigational Site
      • East Lansing, Michigan, United States, 48823
        • Novo Nordisk Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64108-4619
        • Novo Nordisk Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68198-2168
        • Novo Nordisk Investigational Site
    • New York
      • Brooklyn, New York, United States, 11201-5425
        • Novo Nordisk Investigational Site
      • Valhalla, New York, United States, 10595
        • Novo Nordisk Investigational Site
    • Ohio
      • Dayton, Ohio, United States, 45404
        • Novo Nordisk Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97239-3098
        • Novo Nordisk Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Novo Nordisk Investigational Site
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Novo Nordisk Investigational Site
      • 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

No older than 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male patients with severe (baseline FVIII less than or equal to 1%) haemophilia A
  • Age below 12 years and weight at least 11 kg

Exclusion Criteria:

  • Surgery planned to occur during trial participation (exceptions are port placement, dental extractions, and minor, uncomplicated emergent procedures)
  • Congenital or acquired coagulation disorders other than haemophilia A
  • Any history of FVIII inhibitors (greater than or equal to 0.6 BU/mL)

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rFVIII
Drug: turoctocog alfa
Subjects will be treated 3 times per week or every second day with intravenous injections of turoctocog alfa. The dose range for preventive treatment is 25-60 IU/kg body weight depending on treatment regimen.
Drug: turoctocog alfa
Subjects will undergo half-life evaluation of their current factor VIII product and pharmacokinetic session with turoctocog alfa before entering preventive treatment (subjects with available evaluation of terminal half-life within the last year are to be excluded from receiving factor VIII). Intravenous injections. The dose range for preventive treatment is 25-60 IU/kg body weight depending on treatment regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU))
Time Frame: The adverse events were collected throughout the trial, corresponding to an average of 138 days per subject.
The incidence rate of FVIII inhibitors was calculated by including all patients with inhibitors in the nominator and including all patients with a minimum 50 exposure plus any patients with less than 50 exposures but with inhibitors in denominator.
The adverse events were collected throughout the trial, corresponding to an average of 138 days per subject.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Adverse Events (AEs)
Time Frame: The adverse events were collected throughout the trial, corresponding to an average of 138 days per subject
Adverse event was defined as events occurring after administration of trial product. Severe AEs: considerable interference with subject's daily activities, unacceptable. Moderate AEs: Marked symptoms, moderate interference with the patient's daily activities. Mild AEs: No or transient symptoms, no interference with the patient's daily activities. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.
The adverse events were collected throughout the trial, corresponding to an average of 138 days per subject

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

June 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

May 28, 2010

First Submitted That Met QC Criteria

June 4, 2010

First Posted (Estimate)

June 7, 2010

Study Record Updates

Last Update Posted (Actual)

March 17, 2017

Last Update Submitted That Met QC Criteria

February 9, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN7008-3545
  • U1111-1113-7182 (Other Identifier: WHO)
  • 2009-016383-36 (EudraCT Number)

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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