CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 86 enrolled
Drug / intervention
eptacog alfa (activated)drug
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/NCT00882778
NCT00882778N/ACompleted
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Prophylactic Treatment With Recombinant Factor VIIa (rFVIIa, NovoSeven®) in Haemophilia Patients With Inhibitors

Novo Nordisk A/S·observational·Posted Apr 16, 2009·Updated Jan 9, 2017

In Brief

An observational study evaluating eptacog alfa (activated) for Congenital Bleeding Disorder and 2 related conditions. Completed, enrolled 86 participants across 14 sites in 14 countries.

Detailed Summary

This study is conducted in Europe and North and South America. The primary aim of this observational study is to evaluate the frequency and pattern of bleeding episodes in haemophilia patients receiving preventative treatment with activated recombinant human factor VII. The secondary aim is to evaluate which patients are selected for this treatment, the dose and dose intervals used, and the safety of activated recombinant human factor VII when used as prevention. The study also aims to increase understanding of the unmet medical need and clinical relevance of preventative treatment in haemophilia patients.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
CountriesArgentina, Canada, Croatia, Czechia, France, Germany, Ireland, Italy, Slovakia, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 16, 2009
Enrollment StartApr 1, 2009
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 17.2 years ago

Interventions

eptacog alfa (activated)drug

Retrospective data collection of the use of activated recombinant human factor VII as prophylaxis in haemophilia patients with inhibitors