Clinical Trials Directory

Trials / Completed

CompletedNCT00703911

Observational Registry of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors

A Prospective Observational Registry on the Use of NovoSeven® (Activated Recombinant Human Factor VIIa) for on Demand Treatment of Mild to Moderate Bleeds in Haemophilia A and B Patients With Inhibitors

Status
Completed
Phase
Study type
Observational
Enrollment
102 (actual)
Sponsor
Novo Nordisk A/S · Industry
Sex
Male
Age
Healthy volunteers
Not accepted

Summary

This study was conducted in Africa, Europe, the Middle-East and South America. The primary objective of this registry was to observe the use of single dose and multi-dose use of activated recombinant human factor VII and to compare short-term outcomes, including effectiveness, safety, quality of life and treatment satisfaction with the approved treatments.

Conditions

Interventions

TypeNameDescription
DRUGeptacog alfa (activated)Treatment of patients experiencing bleeds at the discretion of the physician/caregiver

Timeline

Start date
2008-03-01
Primary completion
2010-07-01
Completion
2010-07-01
First posted
2008-06-24
Last updated
2017-01-11
Results posted
2011-12-19

Locations

16 sites across 16 countries: Algeria, Austria, Belgium, Czechia, France, Germany, Italy, Netherlands, Poland, Portugal, Saudi Arabia, South Africa, Sweden, Turkey (Türkiye), United Kingdom, Venezuela

Source: ClinicalTrials.gov record NCT00703911. Inclusion in this directory is not an endorsement.