At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 186 enrolled
Drug / intervention
turoctocog alfa pegoldrug
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 Multi-national Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Patients With Haemophilia A
In Brief
A Phase 3 clinical trial evaluating turoctocog alfa pegol for Congenital Bleeding Disorder and Haemophilia A. Completed, enrolled 186 participants across 93 sites in 24 countries.
Detailed Summary
This trial is conducted globally. The aim of the trial is to evaluate the safety and efficacy, including pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in subjects with Haemophilia A.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Bleeding Disorder, Haemophilia A
CountriesAustralia, Brazil, Bulgaria, Croatia, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Malaysia, Netherlands, Norway, Puerto Rico, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 2011
Enrollment StartJan 2012
Primary CompletionDec 2018
TodayJul 2026
First PostedNov 28, 2011
Enrollment StartJan 30, 2012
Primary CompletionDec 10, 2018
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 14.6 years ago
Interventions
turoctocog alfa pegoldrug
Administered i.v.