At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 51 enrolled

Drug / intervention

eptacog alfa (activated) +5 moredrug

Likely dose

eptacog alfa (activated) 90 mcg/kgfrom 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/NCT00486278

NCT00486278Phase 2Completed

Compare CT.gov

A Multi-centre, Randomised, Double-blinded, Controlled, Dose-escalation Trial on Safety and Efficacy of Activated Recombinant FVII Analogue (NN1731) in the Treatment of Joint Bleeds in Congenital Haemophilia Patients With Inhibitors

Novo Nordisk A/S·interventional·Posted Jun 14, 2007·Updated Mar 7, 2017

In Brief

A Phase 2 clinical trial evaluating eptacog alfa (activated) and vatreptacog alfa (activated) for Congenital Bleeding Disorder and 2 related conditions. Completed, enrolled 51 participants across 45 sites in 18 countries.

Detailed Summary

This trial is conducted in Africa, Asia, Europe, Japan, and North and South America. The aim of this trial is to evaluate the safety and efficacy of activated recombinant human factor VII analogue (vatreptocog alfa (activated)) in haemophilia patients with inhibitors.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsCongenital Bleeding Disorder, Haemophilia A, Haemophilia B

CountriesArgentina, Brazil, Canada, Croatia, France, Hungary, Israel, Italy, Japan, Malaysia, Poland, South Africa, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States

Collaborators--

Timeline

Phase 2CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJun 2007

First PostedJun 2007

Primary CompletionJun 2010

TodayJul 2026

First PostedJun 14, 2007

Enrollment StartJun 1, 2007

Primary CompletionJun 1, 2010

TodayJul 2, 2026

Enrollment to primary: 3 yearsPosted 19.1 years ago