Clinical Trials Logo
  1. Home
  2. Congenital Bleeding Disorder
  3. NCT02035384
  4. Details
NCT02035384 Clinical Trial

Safety and Efficacy of Turoctocog Alfa During Long-Term Treatment of Severe and Moderately Severe Haemophilia A

Congenital Bleeding Disorder Clinical Trial

— guardian™ 5  

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%)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02035384
Other study ID # NN7008-3553
Secondary ID U1111-1126-0353E
Status Completed
Phase
First received
Last updated
Start date June 5, 2014
Est. completion date January 15, 2020

Study information
Verified date April 2020
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 69
Est. completion date January 15, 2020
Est. primary completion date January 15, 2020
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Austria Novo Nordisk Investigational Site Graz
Austria Novo Nordisk Investigational Site Linz
Czechia Novo Nordisk Investigational Site Brno
France Novo Nordisk Investigational Site Bordeaux
France Novo Nordisk Investigational Site Montmorency
France Novo Nordisk Investigational Site Rennes
France Novo Nordisk Investigational Site Saint Etienne
France Novo Nordisk Investigational Site Strasbourg
Germany Novo Nordisk Investigational Site Braunschweig
Germany Novo Nordisk Investigational Site Duisburg
Germany Novo Nordisk Investigational Site Frankfurt / Main
Germany Novo Nordisk Investigational Site Giessen
Germany Novo Nordisk Investigational Site Leipzig
Germany Novo Nordisk Investigational Site Mörfelden-Walldorf
Germany Novo Nordisk Investigational Site München
Germany Novo Nordisk Investigational Site Münster
Greece Novo Nordisk Investigational Site Athens
Hungary Novo Nordisk Investigational Site Budapest
Hungary Novo Nordisk Investigational Site Debrecen
Hungary Novo Nordisk Investigational Site Mohács
Italy Novo Nordisk Investigational Site Castelfranco Veneto
Italy Novo Nordisk Investigational Site Catania
Italy Novo Nordisk Investigational Site Firenze
Italy Novo Nordisk Investigational Site Padova
Italy Novo Nordisk Investigational Site Palermo
Netherlands Novo Nordisk Investigational Site Den Haag
Netherlands Novo Nordisk Investigational Site Utrecht
Poland Novo Nordisk Investigational Site Warszawa
Slovakia Novo Nordisk Investigational Site Banska Bystrica
Slovakia Novo Nordisk Investigational Site Kosice
Slovenia Novo Nordisk Investigational Site Ljubljana
Spain Novo Nordisk Investigational Site Barcelona
Sweden Novo Nordisk Investigational Site Malmö
Sweden Novo Nordisk Investigational Site Stockholm
Switzerland Novo Nordisk Investigational Site Zürich
United States Novo Nordisk Investigational Site Albuquerque New Mexico
United States Novo Nordisk Investigational Site Charlotte North Carolina
United States Novo Nordisk Investigational Site Mobile Alabama
United States Novo Nordisk Investigational Site Peoria Illinois
United States Novo Nordisk Investigational Site Salt Lake City Utah
United States Novo Nordisk Investigational Site Torrance California

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Austria,  Czechia,  France,  Germany,  Greece,  Hungary,  Italy,  Netherlands,  Poland,  Slovakia,  Slovenia,  Spain,  Sweden,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Within approximately 7 years
Secondary Number of adverse reactions reported During approximately 7 years
Secondary Number of serious adverse reactions reported During approximately 7 years
Secondary 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 Within approximately 7 years
Secondary 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 Within approximately 7 years
Secondary Annualised bleeding rate for patients using turoctocog alfa for preventive treatment Within approximately 7 years
Secondary Annualised bleeding rate for patients using turoctocog alfa for on-demand treatment Within approximately 7 years
See also
  Status Clinical Trial Phase
Completed NCT00978380 - Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725 Phase 3
Completed NCT02568202 - Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S) N/A
Completed NCT01949792 - A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors Phase 1
Completed NCT01205724 - Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A Phase 1
Completed NCT01562587 - Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non- Bleeding State Phase 1
Completed NCT00108797 - Trial of NovoSeven® in Haemophilia - Joint Bleeds Phase 4
Completed NCT01493778 - Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A Phase 3
Completed NCT02490787 - Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects Phase 1
Completed NCT00951405 - Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With Inhibitors Phase 2
Completed NCT01876745 - A Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan N/A
Completed NCT02920398 - A Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A Phase 1
Completed NCT00984126 - Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015 Phase 3
Completed NCT01228669 - Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B Phase 1
Completed NCT01988532 - Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia N/A
Completed NCT01234545 - Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors N/A
Completed NCT01779921 - Treatment of Congenital Factor VII Deficiency N/A
Completed NCT01563471 - Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers Phase 1
Completed NCT02941354 - Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A Phase 1
Completed NCT02241694 - To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives N/A
Completed NCT01238367 - A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543 Phase 1

External Links