Safety and Efficacy of Turoctocog Alfa During Long-Term Treatment of Severe and Moderately Severe Haemophilia A (guardian™ 5)

April 24, 2020 updated by: Novo Nordisk A/S

A Multi-centre Non-interventional Study of Safety and Efficacy of Turoctocog Alfa (rFVIII) During Long-Term Treatment of Severe and Moderately Severe Haemophilia A (FVIII =<2%)

This study is conducted in Europe, and North and South America. The aim of this study is to provide additional documentation of the immunogenicity, and obtain additional clinical data, of turoctocog alfa in the setting of normal clinical practise in patients previously treated with a factor VIII agent (FVIII).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

69

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

  • Austria
      • Graz, Austria, 8036
        • Novo Nordisk Investigational Site
      • Linz, Austria, 4020
        • Novo Nordisk Investigational Site
  • Czechia
      • Brno, Czechia, 625 00
        • Novo Nordisk Investigational Site
  • France
      • Bordeaux, France, 33076
        • Novo Nordisk Investigational Site
      • Montmorency, France, 95160
        • Novo Nordisk Investigational Site
      • Rennes, France, 35033
        • Novo Nordisk Investigational Site
      • Saint Etienne, France, 42055
        • Novo Nordisk Investigational Site
      • Strasbourg, France, 67098
        • Novo Nordisk Investigational Site
  • Germany
      • Braunschweig, Germany, 38118
        • Novo Nordisk Investigational Site
      • Duisburg, Germany, 47051
        • Novo Nordisk Investigational Site
      • Frankfurt / Main, Germany, 60596
        • Novo Nordisk Investigational Site
      • Giessen, Germany, 35392
        • Novo Nordisk Investigational Site
      • Leipzig, Germany, 04289
        • Novo Nordisk Investigational Site
      • Mörfelden-Walldorf, Germany, 64546
        • Novo Nordisk Investigational Site
      • München, Germany, 80331
        • Novo Nordisk Investigational Site
      • Münster, Germany, 48143
        • Novo Nordisk Investigational Site
  • Greece
      • Athens, Greece, GR-11527
        • Novo Nordisk Investigational Site
  • Hungary
      • Budapest, Hungary, H-1134
        • Novo Nordisk Investigational Site
      • Debrecen, Hungary, 4032
        • Novo Nordisk Investigational Site
      • Mohács, Hungary, 7700
        • Novo Nordisk Investigational Site
  • Italy
      • Castelfranco Veneto, Italy, 31033
        • Novo Nordisk Investigational Site
      • Catania, Italy, 95123
        • Novo Nordisk Investigational Site
      • Firenze, Italy, 50134
        • Novo Nordisk Investigational Site
      • Padova, Italy, 35128
        • Novo Nordisk Investigational Site
      • Palermo, Italy, 90127
        • Novo Nordisk Investigational Site
  • Netherlands
      • Den Haag, Netherlands, 2545AA
        • Novo Nordisk Investigational Site
      • Utrecht, Netherlands, 3584 CX
        • Novo Nordisk Investigational Site
  • Poland
      • Warszawa, Poland, 02-091
        • Novo Nordisk Investigational Site
  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
        • Novo Nordisk Investigational Site
      • Kosice, Slovakia, 04001
        • Novo Nordisk Investigational Site
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Novo Nordisk Investigational Site
  • Spain
      • Barcelona, Spain, 08035
        • Novo Nordisk Investigational Site
  • Sweden
      • Malmö, Sweden, 205 02
        • Novo Nordisk Investigational Site
      • Stockholm, Sweden, 171 76
        • Novo Nordisk Investigational Site
  • Switzerland
      • Zürich, Switzerland, 8091
        • Novo Nordisk Investigational Site
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36604
        • Novo Nordisk Investigational Site
    • California
      • Torrance, California, United States, 90502-2004
        • Novo Nordisk Investigational Site
    • Illinois
      • Peoria, Illinois, United States, 61615
        • Novo Nordisk Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Novo Nordisk Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Novo Nordisk Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Previously FVIII treated (more than 150 exposure days) patients with severe and moderately severe haemophilia A with FVIII below or equal to 2%.

Description

Inclusion Criteria:

  • Informed consent obtained before any study-related activities. Study-related activities are any procedure related to recording of data according to the protocol
  • Previously FVIII treated (150 exposure days at the time of first dosing with turoctocog alfa) male patients with the diagnosis of severe and moderately severe haemophilia A (FVIII below or equal to 2%)
  • The decision to initiate treatment with commercially available turoctocog alfa has been made by the patient/parent and the patient's treating physician before and independently from the decision to include the patient in this study
  • A negative FVIII inhibitor test obtained not more than four weeks prior to first dosing with turoctocog alfa

Exclusion Criteria:

  • Contraindications for use according to the approved product information text (US Package insert (PI), European Summary of Product Characteristics (SmPC), or corresponding local prescribing information)
  • Treatment with any investigational drug within 30 days prior to enrolment into the study
  • Previous participation in any clinical trial with turoctocog alfa
  • Treatment with other FVIII products after initiation of treatment with turoctocog alfa

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All patients
Drug: turoctocog alfa
Patients will be treated with commercially available turoctocog alfa as prescribed by the treating physician in clinical daily practice and preferably according to the label for turoctocog alfa in the respective countries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence rate of FVIII inhibitors (at least 0.6 Bethesda Units (BU) for central laboratory analyses, or above the specific local laboratory reference range) represented as the percentage of patients developing inhibitors
Time Frame: Within approximately 7 years
Within approximately 7 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of adverse reactions reported
Time Frame: During approximately 7 years
During approximately 7 years
Number of serious adverse reactions reported
Time Frame: During approximately 7 years
During approximately 7 years
Haemostatic effect of turoctocog alfa in the treatment of bleeds as assessed by the patient or the physician according to a predefined four point scale: Excellent, Good, Moderate, or None
Time Frame: Within approximately 7 years
Within approximately 7 years
Haemostatic effect of turoctocog alfa during surgical procedures as assessed by an evaluation according to a predefined four point scale: Excellent, Good, Moderate, or None
Time Frame: Within approximately 7 years
Within approximately 7 years
Annualised bleeding rate for patients using turoctocog alfa for preventive treatment
Time Frame: Within approximately 7 years
Within approximately 7 years
Annualised bleeding rate for patients using turoctocog alfa for on-demand treatment
Time Frame: Within approximately 7 years
Within approximately 7 years

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.

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 (Actual)

June 5, 2014

Primary Completion (Actual)

January 15, 2020

Study Completion (Actual)

January 15, 2020

Study Registration Dates

First Submitted

January 10, 2014

First Submitted That Met QC Criteria

January 10, 2014

First Posted (Estimate)

January 14, 2014

Study Record Updates

Last Update Posted (Actual)

April 27, 2020

Last Update Submitted That Met QC Criteria

April 24, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN7008-3553
  • U1111-1126-0353 (Other Identifier: WHO)
  • ENCEPP/SDPP/5501 (Registry Identifier: EU PAS)

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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