Efficacy and Safety of N8 in Haemophilia A Subjects


Tracking Information

Start Date  ICMJEApril 2009
Estimated Primary Completion DateAugust 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: February 9, 2009)		Amount of N8 used and bleeding rates and response to treatment as assessed by the physician, patient or caregiver [ Time Frame: during 6-8 months of treatment ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00840086 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: February 9, 2009)		Inhibitor development [ Time Frame: during 6-8 months of treatment ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEEfficacy and Safety of N8 in Haemophilia A Subjects
Official Title  ICMJEA Multi-centre, Open-label, Non-controlled Trial on Efficacy and Safety of N8 in Prevention and On-demand Treatment of Bleeding Episodes in Previously Treated Subjects With Haemophilia A. Sub-trial: Efficacy and Safety of N8 in Prevention and Treatment of Bleeding During Surgical Procedures in Subjects With Haemophilia A
Brief Summary

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

The trial consists of a main trial and a sub-trial. The main trial investigates efficacy and safety of recombinant factor VIII (N8) in haemophilia A subjects, while the sub-trial investigates efficacy and safety of N8 in prevention and treatment of bleeding during surgical procedures.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition  ICMJEHaemophilia A
Intervention  ICMJE
  • Drug: recombinant factor VIII (N8)
    Subjects will receive bleeding preventive treatment (home treatment with self-injection i.v.) with N8 at a dose of 20-40 IU/kg body weight every second day or 20-50 IU/kg body weight three times per week at the investigator's discretion.
    Other Names:
    • NN7008
    • rFVIII
  • Procedure: Blood drawn for laboratory testing
    Blood drawn for laboratory testing
Study Arms / Comparison GroupsA: Experimental
Interventions:
  • Drug: recombinant factor VIII (N8)
  • Procedure: Blood drawn for laboratory testing

Recruitment Information

Estimated Enrollment  ICMJE140
Estimated Completion DateAugust 2011
Estimated Primary Completion DateAugust 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Severe haemophilia A (FVIII level less than or equal to 1%)
  • Treatment history of more than 150 exposure days with recombinant or plasma-derived FVIII replacement products
  • HIV or HCV negative, or if positive the patient is on a stable antiviral regimen at the time of the enrolment in the trial
  • Sub-trial: Patient to undergo major or minor elective surgery requiring N8 replacement for at least 6 days

Exclusion Criteria:

  • Presence of any bleeding disorder in addition to haemophilia A
  • Inhibitor titer greater than or equal to 0.6 Bethesda Units (BU) at screening and past history of inhibitor
  • Abnormal renal function tests
  • Known hypersensitivity
GenderMale
Ages12 Years to 65 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Novo Nordisk Clinical Trial Call Center866-867-7178
Location Countries  ICMJEUnited States,   Brazil,   Croatia,   Denmark,   Germany,   Hungary,   Israel,   Italy,   Japan,   Russian Federation,   Serbia,   Spain,   Switzerland,   Taiwan,   Turkey,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00840086
Responsible PartyPublic Access to Clinical Trials, Novo Nordisk A/S
Study ID Numbers  ICMJENN7008-3543, EudraCT No: 2008-003960-20
Study Sponsor  ICMJENovo Nordisk
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Mette B. LarsenNovo Nordisk
Study Director:Birgitte DenlowNovo Nordisk
Information Provided ByNovo Nordisk