At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 60 enrolled
Drug / intervention
turoctocog alfadrug
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.
Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Paediatric Previously Untreated Patients With Haemophilia A
In Brief
A Phase 3 clinical trial evaluating turoctocog alfa for Congenital Bleeding Disorder and Haemophilia A. Completed, enrolled 60 participants across 69 sites in 18 countries.
Detailed Summary
This trial is conducted in Asia, Europe and North America. The purpose of the trial is to evaluate the safety and efficacy of turoctocog alfa in prevention and treatment of bleeds in previously untreated children with haemophilia A.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Bleeding Disorder, Haemophilia A
CountriesAlgeria, Austria, Brazil, China, Denmark, Greece, Hong Kong, Hungary, Japan, Lithuania, Poland, Portugal, Puerto Rico, Russia, Serbia, Spain, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 2011
Enrollment StartSep 2012
Primary CompletionAug 2017
Study CompletionDec 2018
TodayJul 2026
First PostedDec 16, 2011
Enrollment StartSep 17, 2012
Primary CompletionAug 16, 2017
Study CompletionDec 5, 2018
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 14.5 years ago
Interventions
turoctocog alfadrug
Patients will be scheduled to receive treatment with turoctocog alfa for at least 100 exposure days. In most cases, treatment will be given at home with intravenous (i.v., into the vein) self-injection by the parent/caregiver/support person.