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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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: September 21, 2009
Last updated: December 8, 2016
Last verified: December 2016

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).

Condition Intervention Phase
Congenital Bleeding Disorder
Haemophilia A
Drug: turoctocog alfa
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of N8 in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Frequency of development of FVIII inhibitors (greater than or equal to 0.6 Bethesda Units (BU)/mL) [ Time Frame: After 90 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Frequency of Adverse Events (AEs), Serious Adverse Events (SAEs) and Medical Events of Special Interest (MESIs) reported [ Time Frame: After 90 months ] [ Designated as safety issue: Yes ]
  • Average number of bleeds per month reported during the prevention period [ Time Frame: After 90 months ] [ Designated as safety issue: No ]
  • Haemostatic response to turoctocog alfa (none, moderate, good or excellent) in treatment of bleeds. [ Time Frame: After 90 months ] [ Designated as safety issue: No ]

Enrollment: 214
Study Start Date: October 2009
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Turoctocog alfa 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.
Drug: turoctocog alfa
Treatment is administered intravenously (i.v.) during bleeds and occasionally as a preventative treatment (e.g. before physical activity)


Ages Eligible for Study:   6 Months to 70 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00984126

  Show 57 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00984126     History of Changes
Other Study ID Numbers: NN7008-3568  2008-005945-46  U1111-1111-9377  JapicCTI-101357 
Study First Received: September 21, 2009
Last Updated: December 8, 2016
Health Authority: Brazil: National Health Surveillance Agency
Croatia: Ministry of Health and Social Care
Germany: Paul-Ehrlich-Institut
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Japan: Ministry of Health, Labor and Welfare
Latvia: Ministry of Health
Lithuania: Lithuanian Bioethics Committee
Macedonia, The Former Yugoslav Republic of: Ministry of Health of Republic of Macedonia
Malaysia: Ministry of Health
Poland: Ministry of Health
Russia: Federal Service for Control of Health Care and Social Development
Serbia: Medicines and Medical Devices Agency of Serbia
Spain: Spanish agency of medicines and health care products
Switzerland: Swissmedic
Taiwan: Department of Health, Executive Yuan, R.O.C.
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

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
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Factor VIII
Coagulants processed this record on January 14, 2017