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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00703911
• Date of registration: 19/06/2008
• Primary sponsor: Novo Nordisk
• Public title: Observational Registry of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors ONE
• Scientific title: A Prospective Observational Registry on the Use of NovoSeven® (Activated Recombinant Human Factor VIIa) for on Demand Treatment of Mild to Moderate Bleeds in Haemophilia A and B Patients With Inhibitors
• Date of first enrolment: March 2008
• Target sample size: 102
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00703911
• Study type: Observational
• Study design: Time Perspective: Prospective

Countries of recruitment

Algeria, Argentina, Australia, Austria, Belgium, Canada, Costa Rica, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Turkey, United Kingdom, Venezuela

Contacts

• Name: Paulo André Palhares de Miranda
• Affiliation: Novo Nordisk Health Care AG

Key inclusion & exclusion criteria

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 activated recombinant human factor VII

- 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participation (not applicable if patient is withdrawn)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 activated recombinant human factor VII, or to mouse, hamster or bovine protein



Age minimum: N/A
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Haemophilia

Haemophilia A

Haemophilia B

Intervention(s)

Drug: activated recombinant human factor VII

Primary Outcome(s)

Percentage of Bleed Treatments Resulting in Effective Bleed Resolution (All Bleed Episodes) [Time Frame: within 9 hours of first injection]

Percentage of Bleed Treatments Resulting in Effective Bleed Resolution (Spontaneous Bleed Episodes) [Time Frame: within 9 hours of first injection]

Percentage of Bleed Treatments Resulting in Effective Pain Relief (All Bleed Episodes) [Time Frame: within 9 hours of first injection]

Percentage of Bleed Treatments Resulting in Effective Pain Relief (Spontaneous Bleed Episodes) [Time Frame: within 9 hours of first injection]

Secondary Outcome(s)

Overall Time to Cessation of Bleed/Achievement of Haemostasis (All Bleed Episodes) [Time Frame: duration of bleed episode]

Overall Time to Cessation of Bleed/Achievement of Haemostasis (Spontaneous Bleed Episodes) [Time Frame: duration of bleed episode]

Overall Time to Cessation/Achievement of Haemostasis (Spontaneous Bleed Episodes) [Time Frame: duration of bleed episode]

Percentage of Bleed Treatments Resulting in Effective Haemostasis (Cessation of Bleeds) by Time Point (All Bleed Episodes) [Time Frame: 1 hour, 3 hours and 6 hours, respectively, after first injection]

Percentage of Bleed Treatments Resulting in Effective Haemostasis (Cessation of Bleeds) by Time Point (Spontaneous Bleed Episodes) [Time Frame: 1 hour, 3 hours and 6 hours, respectively, after first injection]

Percentage of Bleed Treatments Resulting in Effective Pain Relief by Time Point (All Bleed Episodes) [Time Frame: 1 hour, 3 hours and 6 hours, respectively, after first injection]

Percentage of Bleed Treatments Resulting in Effective Pain Relief by Time Point (Spontaneous Bleed Episodes) [Time Frame: 1 hour, 3 hours and 6 hours, respectively, after first injection]

Percentage of Bleed Treatments Resulting in Patient Satisfaction With Ease of Use (All Bleed Episodes) [Time Frame: duration of bleed episode]

Percentage of Bleed Treatments Resulting in Patient Satisfaction With Ease of Use (Spontaneous Bleed Episodes) [Time Frame: duration of bleed episode]

Percentage of Bleed Treatments Resulting in Patient Satisfaction With Symptom Relief (Spontaneous Bleed Episodes) [Time Frame: duration of bleed episode]

Percentage of Patients Reporting Satisfaction With Symptom Relief (All Bleed Episodes) [Time Frame: duration of bleed episode]

Quality of Life Questionnaire (Voluntary) [Time Frame: at study discontinuation]

Total Exposure (Cumulative Dose) to Activated Recombinant Human Factor VII (All Bleed Episodes) [Time Frame: individual bleed episode]

Total Exposure (Cumulative Dose) to Activated Recombinant Human Factor VII (Spontaneous Bleed Episodes) [Time Frame: individual bleed episode]

Total Number of Injections (All Bleed Episodes) [Time Frame: individual bleed episode]

Total Number of Injections (Spontaneous Bleed Episodes) [Time Frame: individual bleed episode]

Secondary ID(s)

F7HAEM-3507

Source(s) of Monetary Support

Please refer to primary and secondary sponsors