CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 65 enrolled
Drug / intervention
turoctocog alfa +1 moredrug
Likely dose
turoctocog alfa 60 IUfrom 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.

Search/NCT01138501
NCT01138501Phase 3Completed
CompareCT.gov

A Multi-Centre, Open-Label, Non-Controlled Trial on Safety and Efficacy of N8 in Previously Treated Paediatric Patients With Haemophilia A

Novo Nordisk A/S·interventional·Posted Jun 7, 2010·Updated Mar 17, 2017

In Brief

A Phase 3 clinical trial evaluating turoctocog alfa for Congenital Bleeding Disorder and Haemophilia A. Completed, enrolled 65 participants across 38 sites in 13 countries.

Detailed Summary

This trial is conducted in Asia, Europe, and North and South America. The aim of this clinical trial is to investigate the safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in male previously treated paediatric subjects with haemophilia A.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Bleeding Disorder, Haemophilia A
CountriesBrazil, Italy, Japan, Lithuania, Malaysia, North Macedonia, Poland, Puerto Rico, Russia, Serbia, Taiwan, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 7, 2010
Enrollment StartJun 1, 2010
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 16.1 years ago

Interventions

turoctocog alfadrug

Subjects will be treated 3 times per week or every second day with intravenous injections of turoctocog alfa. The dose range for preventive treatment is 25-60 IU/kg body weight depending on treatment regimen.

turoctocog alfadrug

Subjects will undergo half-life evaluation of their current factor VIII product and pharmacokinetic session with turoctocog alfa before entering preventive treatment (subjects with available evaluation of terminal half-life within the last year are to be excluded from receiving factor VIII). Intravenous injections. The dose range for preventive treatment is 25-60 IU/kg body weight depending on treatment regimen.