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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02035384
First Posted: January 14, 2014
Last Update Posted: November 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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).

Condition Intervention
Congenital Bleeding Disorder Haemophilia A Drug: turoctocog alfa

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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%)

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Number of adverse reactions reported [ Time Frame: During approximately 7 years ]
  • Number of serious adverse reactions reported [ Time Frame: 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 ]
  • 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 ]
  • Annualised bleeding rate for patients using turoctocog alfa for preventive treatment [ Time Frame: Within approximately 7 years ]
  • Annualised bleeding rate for patients using turoctocog alfa for on-demand treatment [ Time Frame: Within approximately 7 years ]

Estimated Enrollment: 70
Actual Study Start Date: June 4, 2014
Estimated Study Completion Date: April 11, 2021
Estimated Primary Completion Date: April 1, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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%.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035384


  Show 35 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02035384     History of Changes
Other Study ID Numbers: NN7008-3553
U1111-1126-0353 ( Other Identifier: WHO )
ENCEPP/SDPP/5501 ( Registry Identifier: EU PAS )
First Submitted: January 10, 2014
First Posted: January 14, 2014
Last Update Posted: November 16, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Vascular Diseases
Cardiovascular Diseases
Factor VIII
Coagulants