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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.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00984126
First received: September 21, 2009
Last updated: May 30, 2017
Last verified: May 2017
  Purpose

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
Intervention Model: Parallel Assignment
Masking: No masking
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 ]

Secondary Outcome Measures:
  • Frequency of adverse events and serious adverse events [ Time Frame: After 90 months ]
  • Average number of bleeds per month reported during the prevention period [ Time Frame: After 90 months ]
  • Haemostatic response to turoctocog alfa (none, moderate, good or excellent) in treatment of bleeds. [ Time Frame: After 90 months ]

Enrollment: 214
Actual Study Start Date: October 26, 2009
Study Completion Date: June 29, 2016
Primary Completion Date: June 28, 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)

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00984126

  Show 57 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:
Publications:
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 - Special Issue: Abstracts of the WFH 2014 World Congress, May 11-15, Melbourne, Australia; 20 (3): 1-200
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 Annual Meeting (ASH); Country: US City: San Francisco, CA

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00984126     History of Changes
Other Study ID Numbers: NN7008-3568
2008-005945-46 ( EudraCT Number )
U1111-1111-9377 ( Other Identifier: WHO )
JapicCTI-101357 ( Registry Identifier: JAPIC )
Study First Received: September 21, 2009
Last Updated: May 30, 2017

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

ClinicalTrials.gov processed this record on June 22, 2017