At a glance
ClinicalIndex Comparison RecordN/ACompleted· 102 enrolled
Drug / intervention
eptacog alfa (activated)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
An observational study evaluating eptacog alfa (activated) for Congenital Bleeding Disorder and 2 related conditions. Completed, enrolled 102 participants across 16 sites in 16 countries.
Detailed Summary
This study was conducted in Africa, Europe, the Middle-East and South America. The primary objective of this registry was to observe the use of single dose and multi-dose use of activated recombinant human factor VII and to compare short-term outcomes, including effectiveness, safety, quality of life and treatment satisfaction with the approved treatments.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
CountriesAlgeria, Austria, Belgium, Czechia, France, Germany, Italy, Netherlands, Poland, Portugal, Saudi Arabia, South Africa, Sweden, Turkey (Türkiye), United Kingdom, Venezuela
Collaborators--
Timeline
N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2008
First PostedJun 2008
Primary CompletionJul 2010
TodayJul 2026
First PostedJun 24, 2008
Enrollment StartMar 1, 2008
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.0 years ago
Interventions
eptacog alfa (activated)drug
Treatment of patients experiencing bleeds at the discretion of the physician/caregiver