At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 72 enrolled
Drug / intervention
vatreptacog alfa (activated) +1 moredrug
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.
Efficacy and Safety of NNC 0078-0000-0007 in Treatment of Acute Bleeding Episodes in Patients With Congenital Haemophilia and Inhibitors
In Brief
A Phase 3 clinical trial evaluating vatreptacog alfa (activated) and eptacog alfa (activated) for Congenital Bleeding Disorder and 2 related conditions. Completed, enrolled 72 participants across 32 sites in 19 countries.
Detailed Summary
This trial is conducted globally. The purpose of this trial is to confirm the efficacy and safety of NNC 0078-0000-0007 in patients with congenital haemophilia and inhibitors.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
CountriesAustria, Brazil, Croatia, Greece, Hungary, Italy, Japan, Malaysia, Poland, Puerto Rico, Romania, Russia, Serbia, South Africa, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2011
First PostedJul 2011
Primary CompletionAug 2012
TodayJul 2026
First PostedJul 12, 2011
Enrollment StartJul 1, 2011
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.0 years ago
Interventions
vatreptacog alfa (activated)drug
1-3 doses per bleeding episode
eptacog alfa (activated)drug
1-3 doses per bleeding episode