Observational Registry of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors (ONE)


Tracking Information

Start Date  ICMJEMarch 2008
Estimated Primary Completion DateJuly 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: June 23, 2008)
  • Proportion of bleed treatments resulting in effective haemostasis [ Time Frame: 9 hours after first injection, for each bleeding episode ] [ Designated as safety issue: No ]
  • Proportion of bleed treatments resulting in effective pain relief [ Time Frame: 9 hours after first injection, for each bleeding episode ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00703911 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: June 23, 2008)
  • Treatment satisfaction and convenience [ Time Frame: after each bleeding episode ] [ Designated as safety issue: No ]
  • Haemostasis/pain relief [ Time Frame: 1 hour, 3 hours and 6 hours after start of each bleed ] [ Designated as safety issue: No ]
  • Adverse events reported as potentially related to NovoSeven [ Time Frame: up to 28 days after discontinuation from the study ] [ Designated as safety issue: Yes ]
  • Total number of injections/doses [ Time Frame: 48 hours after start of each bleed ] [ Designated as safety issue: No ]
  • Quality of Life questionnaire (voluntary) [ Time Frame: at study discontinuation ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEObservational Registry of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors
Official Title  ICMJEEfficacy and Safety of NovoSeven® (Activated Recombinant Human Factor VII) Used as On-demand Treatment of Mild to Moderate Bleeds in Patients With Haemophilia A and B With Inhibitors
Brief Summary

This study is conducted in Europe. The primary objective of this registry is to observe the use of single dose and multi-dose use of NovoSeven® and to compare short-term outcomes, including effectiveness, safety, quality of life and treatment satisfaction with the approved treatments.

Detailed Description 
Study Phase 
Study Type  ICMJEObservational
Study Design  ICMJEOther, Prospective
Condition  ICMJE
  • Haemophilia A
  • Haemophilia B
Intervention  ICMJEDrug: activated recombinant human factor VII
Treatment of patients experiencing bleeds at the discretion of the physician/caregiver.
Other Name: NovoSeven®
Study Arms / Comparison GroupsA
Intervention: Drug: activated recombinant human factor VII

Recruitment Information

Estimated Enrollment  ICMJE60
Estimated Completion DateJuly 2010
Estimated Primary Completion DateJuly 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosed with haemophilia A or B with inhibitors
  • Experience mild to moderate spontaneous bleeds which require on-demand treatment and who are currently prescribed NovoSeven
  • Be able and willing to provide informed consent (or proxy consent by caregiver, if applicable), as required by local research ethics committee, governmental or regulatory authorities.
  • Be willing to provide information on at least one alternate contact person in the event that the patient be somehow lost-to-follow-up over the course of registry participation (not applicable if patient is withdrawn).

Exclusion Criteria:

  • Known hypersensitivity to the active substance or the excipients in the formulation of NovoSeven, or to mouse, hamster or bovine protein
GenderMale
Ages 
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Public Access to Clinical Trials - Novo NordiskPlease Contact NN via emailclinicaltrials@novonordisk.com
Location Countries  ICMJEAlgeria,   Argentina,   Australia,   Austria,   Belgium,   Costa Rica,   Czech Republic,   France,   Germany,   Italy,   Netherlands,   Poland,   Portugal,   Russian Federation,   Saudi Arabia,   South Africa,   Spain,   Sweden,   Turkey,   United Kingdom,   Venezuela

Administrative Information

NCT ID  ICMJENCT00703911
Responsible PartyPublic Access to Clinical Trials, Novo Nordisk A/S
Study ID Numbers  ICMJEF7HAEM-3507
Study Sponsor  ICMJENovo Nordisk
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Paulo André Palhares de MirandaNovo Nordisk Health Care AG
Information Provided ByNovo Nordisk