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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00984126
First received: September 21, 2009
Last updated: March 31, 2014
Last verified: March 2014

September 21, 2009
March 31, 2014
October 2009
June 2016   (final data collection date for primary outcome measure)
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 ]
  • Frequency of development of FVIII inhibitors (greater than or equal to 0.6 BU/mL) [ Time Frame: after 42 months ] [ Designated as safety issue: Yes ]
  • Frequency of Adverse Events (AEs), Serious Adverse Events (SAEs) and Medical Events of Special Interests (MESIs) reported [ Time Frame: after 42 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00984126 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Average number of bleeds per month reported during the prevention period [ Time Frame: after 42 months ] [ Designated as safety issue: No ]
  • Haemostatic response to N8 (none, moderate, good or excellent) in treatment of bleeds. [ Time Frame: after 42 months ] [ Designated as safety issue: No ]
  • Frequency of Adverse Events (AEs), Serious Adverse Events (SAEs) and Medical Events of Special Interests (MESIs) reported [ Time Frame: from presurgery at visit 1 to end of recovery period at visit 14 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
Safety and Efficacy of N8 in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A

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.

This 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).

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Congenital Bleeding Disorder
  • Haemophilia A
  • 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)
Experimental: Turoctocog alfa
Interventions:
  • Drug: turoctocog alfa
  • Drug: turoctocog alfa
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
214
June 2016
June 2016   (final data collection date for primary outcome measure)

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
Male
6 Months to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
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
 
NCT00984126
NN7008-3568, 2008-005945-46, U1111-1111-9377, JapicCTI-101357
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP