Safety and Efficacy of N8 in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543 and NN7008-3545


Tracking Information

Start Date  ICMJEOctober 2009
Estimated Primary Completion DateApril 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: September 24, 2009)
  • 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 ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00984126 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: September 24, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJESafety and Efficacy of N8 in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543 and NN7008-3545
Official Title  ICMJESafety and Efficacy of N8 in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A
Brief Summary

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

The aim of this clinical trial is to investigate safety and efficacy of N8 in Haemophilia A patients.

This trial is an extension to trials NN7008-3543 (start: March 2009, stop: August 2011) and NN7008-3545 (start: April 2010, stop: January 2012)

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEHaemophilia A
Intervention  ICMJE
  • Drug: recombinant factor VIII (N8)
    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 bleeding should occur.
  • Drug: recombinant factor VIII (N8)
    Treatment is administered intravenously (i.v.) during bleeds and occasionally as a preventative treatment (e.g. before physical activity)
Study Arms / Comparison GroupsA: Experimental
Interventions:
  • Drug: recombinant factor VIII (N8)
  • Drug: recombinant factor VIII (N8)

Recruitment Information

Recruitment Status  ICMJERecruiting
Estimated Enrollment  ICMJE145
Estimated Completion DateJune 2018
Estimated Primary Completion DateApril 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Informed Consent obtained before any trial-related activities
  • Completion of trial NN7008-3543 or paedriatric trial NN7008-3545

Exclusion Criteria:

  • Previous participation in the current trial (defined as withdrawal) or withdrawn subjects from NN7008-3522, NN7008-3543 or NN7008-3545 after administration of trial product
GenderMale
Ages6 Months to 70 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Novo Nordisk Clinical Trial Call Center866-867-7178
Location Countries  ICMJEBrazil,   Croatia,   Denmark,   Germany,   Israel,   Russian Federation,   Serbia,   Spain,   Switzerland,   Taiwan,   Turkey,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00984126
Responsible PartyPublic Access to Clinical Trials, Novo Nordisk A/S
Study ID Numbers  ICMJENN7008-3568, EudraCT No: 2008-005945-46, UTN: U1111-1111-9377
Study Sponsor  ICMJENovo Nordisk
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Elisabeth Lynge, BScNovo Nordisk
Information Provided ByNovo Nordisk