Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia

This trial is conducted in Africa, Asia, Europe, South America, and the United States of America (USA).

The purpose of this study is to evaluate the effectiveness of secondary prophylactic treatment with NovoSeven® in haemophilia A and B patients with inhibitors.

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Key information

Conditions

Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors

Age range

2 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site, Ciudad Autónoma de Bs. As., Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of congenital haemophilia A or B with inhibitors development against FVIII or FIX, respectively

Exclusion criteria

Prophylactic administration of any haemostatic drug within 3 last months prior to entering the trial.

Treatment and study plan

activated recombinant human factor VII

Drug

Primary outcomes

Reduction of bleeds

Time frame: During 3 months treatment period as compared to 3 months observation period

Secondary outcomes

Efficacy variables

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Exploratory, Multi-centre, Randomised, Double-blind, Uncontrolled Trial Evaluating the Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Secondary Bleeding Prophylaxis in Congenital Haemophilia A or B Patients With Inhibitors

Important dates

Study start: 2004
Primary completion: 2005
Study completion: 2005
First posted: Apr 19, 2005
Registry last updated: Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed