CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 214 enrolled
Drug / intervention
turoctocog alfa +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.

Search/NCT00984126
NCT00984126Phase 3Completed
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Safety and Efficacy of N8 in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A

Novo Nordisk A/S·interventional·Posted Sep 25, 2009·Updated Jul 27, 2017

In Brief

A Phase 3 clinical trial evaluating turoctocog alfa for Congenital Bleeding Disorder and Haemophilia A. Completed, enrolled 214 participants across 57 sites in 20 countries.

Detailed Summary

This trial is conducted in Asia, Europe, Japan, Oceania, North America and South America. The aim of the trial is to investigate the safety and efficacy of turoctocog alfa (N8) in Haemophilia A patients. The trial is an extension to trials NN7008-3543 (start: March 2009, stop: September 2011) and NN7008-3545 (start: May 2010, stop: November 2011) and the pharmacokinetic trials NN7008-3600 (start: November 2010, stop: October 2011), NN7008-3893 (start: June 2011, stop: September 2011) and NN7008-4015 (start: August 2012, stop: March 2013).

Study Details

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

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 25, 2009
Enrollment StartOct 26, 2009
Primary CompletionJun 28, 2016
Study CompletionJun 29, 2016
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 16.8 years ago

Interventions

turoctocog alfadrug

The preventative treatment is administered intravenously (i.v.) at specific intervals either every second day or three times a week. Bleeding treatment will be administered if a bleed should occur.

turoctocog alfadrug

Treatment is administered intravenously (i.v.) during bleeds and occasionally as a preventative treatment (e.g. before physical activity)