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NCT00984126 Clinical Trial

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

Congenital Bleeding Disorder Clinical Trial

Official title:
Safety and Efficacy of N8 in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00984126
Other study ID # NN7008-3568
Secondary ID 2008-005945-46U1
Status Completed
Phase Phase 3
First received September 21, 2009
Last updated May 30, 2017
Start date October 26, 2009
Est. completion date June 29, 2016

Study information
Verified date May 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial is conducted in Asia, Europe, Japan, Oceania, North America and South America.

The aim of the trial is to investigate the safety and efficacy of turoctocog alfa (N8) in Haemophilia A patients.

The trial is an extension to trials NN7008-3543 (start: March 2009, stop: September 2011) and NN7008-3545 (start: May 2010, stop: November 2011) and the pharmacokinetic trials NN7008-3600 (start: November 2010, stop: October 2011), NN7008-3893 (start: June 2011, stop: September 2011) and NN7008-4015 (start: August 2012, stop: March 2013).

Recruitment information / eligibility
Status Completed
Enrollment 214
Est. completion date June 29, 2016
Est. primary completion date June 28, 2016
Accepts healthy volunteers No
Gender Male
Age group 6 Months to 70 Years
Eligibility Inclusion Criteria:

- Informed Consent obtained before any trial-related activities

- Completion of trial NN7008-3543 or paediatric trial NN7008-3545 or Japanese trial NN7008-3600 or pharmacokinetic trial NN7008-3893 or NN7008-4015

Exclusion Criteria:

- Previous participation in the current trial (defined as withdrawal) or withdrawn subjects from NN7008-3522, NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 or NN7008-4015 after administration of trial product

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• turoctocog alfa
The preventative treatment is administered intravenously (i.v.) at specific intervals either every second day or three times a week. Bleeding treatment will be administered if a bleed should occur.
• turoctocog alfa
Treatment is administered intravenously (i.v.) during bleeds and occasionally as a preventative treatment (e.g. before physical activity)

Locations
Country Name City State
Brazil Novo Nordisk Investigational Site Campinas Sao Paulo
Brazil Novo Nordisk Investigational Site Curitiba Parana
Brazil Novo Nordisk Investigational Site Rio de Janeiro
Brazil Novo Nordisk Investigational Site São Paulo Sao Paulo
Croatia Novo Nordisk Investigational Site Split
Croatia Novo Nordisk Investigational Site Zagreb
Germany Novo Nordisk Investigational Site Berlin
Germany Novo Nordisk Investigational Site Bonn
Germany Novo Nordisk Investigational Site Giessen
Germany Novo Nordisk Investigational Site Hannover
Israel Novo Nordisk Investigational Site Tel Aviv
Israel Novo Nordisk Investigational Site Tel-Hashomer
Italy Novo Nordisk Investigational Site Firenze
Italy Novo Nordisk Investigational Site Milano
Japan Novo Nordisk Investigational Site Kashihara-shi, Nara
Japan Novo Nordisk Investigational Site Nagoya-shi, Aichi
Japan Novo Nordisk Investigational Site Shimotsuke-shi, Tochigi
Japan Novo Nordisk Investigational Site Shinjuku-ku, Tokyo
Japan Novo Nordisk Investigational Site Shizuoka-shi, Shizuoka
Latvia Novo Nordisk Investigational Site Riga
Lithuania Novo Nordisk Investigational Site Vilnius
Macedonia, The Former Yugoslav Republic of Novo Nordisk Investigational Site Skopje
Malaysia Novo Nordisk Investigational Site Kuala Lumpur
Poland Novo Nordisk Investigational Site Warszawa
Poland Novo Nordisk Investigational Site Wroclaw
Puerto Rico Novo Nordisk Investigational Site San Juan
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Saint-Petersburg
Serbia Novo Nordisk Investigational Site Belgrade
Serbia Novo Nordisk Investigational Site Belgrade
Serbia Novo Nordisk Investigational Site Nis
Serbia Novo Nordisk Investigational Site Novi Sad
Spain Novo Nordisk Investigational Site Madrid
Spain Novo Nordisk Investigational Site Valencia
Switzerland Novo Nordisk Investigational Site Zürich
Taiwan Novo Nordisk Investigational Site Taipei
Turkey Novo Nordisk Investigational Site Adana
Turkey Novo Nordisk Investigational Site Antalya
Turkey Novo Nordisk Investigational Site Bornova-IZMIR
Turkey Novo Nordisk Investigational Site Izmit
Turkey Novo Nordisk Investigational Site Samsun
United Kingdom Novo Nordisk Investigational Site London
United Kingdom Novo Nordisk Investigational Site London
United Kingdom Novo Nordisk Investigational Site Manchester
United States Novo Nordisk Investigational Site Atlanta Georgia
United States Novo Nordisk Investigational Site Boston Massachusetts
United States Novo Nordisk Investigational Site Cincinnati Ohio
United States Novo Nordisk Investigational Site Dayton Ohio
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site Iowa City Iowa
United States Novo Nordisk Investigational Site Long Beach California
United States Novo Nordisk Investigational Site Nashville Tennessee
United States Novo Nordisk Investigational Site Phoenix Arizona
United States Novo Nordisk Investigational Site Portland Oregon
United States Novo Nordisk Investigational Site Providence Rhode Island
United States Novo Nordisk Investigational Site Spokane Washington
United States Novo Nordisk Investigational Site Tampa Florida

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

Countries where clinical trial is conducted

United States,  Brazil,  Croatia,  Germany,  Israel,  Italy,  Japan,  Latvia,  Lithuania,  Macedonia, The Former Yugoslav Republic of,  Malaysia,  Poland,  Puerto Rico,  Russian Federation,  Serbia,  Spain,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

References & Publications (4)

Lentz SR, Cerqueira M, Janic D, Kempton C, Matytsina I, Misgav M, Oldenburg J, Ozelo M, Recht M, Rosholm A, Savic A, Suzuki T, Tiede A, Santagostino E. Interim results from a large multinational extension trial (guardian(™) 2) using turoctocog alfa for pr — View Citation

Ozelo M, Misgav M, Abdul Karim F, Lentz SR, Martin-Salces M, Matytsina I, Saugstrup T, Santagostino E. Long-term patterns of safety and efficacy of bleeding prophylaxis with turoctocog alfa (NovoEight(®) ) in previously treated patients with severe haemop — View Citation

Ozelo M, Misgav M, Abdul-Karim F, Lentz S, Martin-Salces M, Matytsina I, Saugstrup T, Santagostino E. Stabilization of turoctocog alfa dose administered in a preventive regimen: 3-year interim results of the guardianTM-2 extension trial. Haemophilia - Spe

Recht M, Lentz S, Zupancic-Salek S, Matytsina I, Landorph A, Saugstrup T. Factor VIII Dosing and Preventive Efficacy in Obese Patients with Hemophilia (BMI =30 kg/m2) - a Post-Hoc Sub-Analysis of the guardian™ Trials. American Society of Hematology - 56th

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of development of FVIII inhibitors (greater than or equal to 0.6 Bethesda Units (BU)/mL) After 90 months
Secondary Frequency of adverse events and serious adverse events After 90 months
Secondary Average number of bleeds per month reported during the prevention period After 90 months
Secondary Haemostatic response to turoctocog alfa (none, moderate, good or excellent) in treatment of bleeds. After 90 months
See also
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