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Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With Inhibitors | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With Inhibitors

An Exploratory Multi-Centre, Multi-National, Randomised, Double Blinded, Parallel Arm Trial Evaluating Safety, Pharmacokinetics and Dose-finding of Prophylactic Administration of Long Acting rFVIIa (LA-rFVIIa) in Haemophilia A or B Patients With Inhibitors

NCT00951405•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

This trial is conducted in Asia, Europe, Japan and North America. The aim of this clinical trial is to investigate the safety and the efficacy of a prophylactic treatment option with long acting coagulation factor VII (LA-rFVIIa) for haemophilia patients with inhibitors.

Eligibility

Age

12 - 65 years

Sex

MALE

Healthy Volunteers

No

Inclusion Criteria

•Male haemophilia A or B patients with inhibitors
•Willing to undergo a bleeding preventive regimen of 3 months' duration and a total trial length of approximately 8 months
•Historical or ongoing high titre inhibitor (more than or equal to 5 BU) based on either medical records, laboratory report reviews, patient and/or care provider interviews
•At least 2 bleeding episodes requiring bypassing haemostatic-drug-based treatment within the last month or 12 bleeding episodes within the last 6 months prior to observation period
•Body weight between 30 and 100 kg (both inclusive)

Exclusion Criteria

•Body Mass Index (BMI) above 30 kg/m2
•Immune tolerance induction therapy within the last month prior to entering observation phase period
•Known active pseudo tumours
•Platelet count less than 50,000 platelets/microL (based on local laboratory value at screening visit)
•Congenital or acquired coagulation disorders other than haemophilia A or B
•Surgery within one month prior to the observation period. Catheter, stents and dental extractions do not count as surgeries, i.e. they will not exclude the patient. Port insertion is classified as surgery
•Scheduled major and/or orthopaedic surgery, during the trial period until Follow up visit. Catheter, stents and dental extractions do not count as surgeries and will not exclude the patient. Port insertion is classified as surgery
•Advanced atherosclerotic disease (i.e. known history of ischemic heart disease, or ischemic stroke)
•Any clinical signs or known history of thromboembolic events incl. known deep vein thrombosis (DVT)
•Known or clinically suspected allergy to activated recombinant human factor VII (NovoSeven®/NovoSeven RT®/Niastase®)
+7 more criteria

Locations (25)

Novo Nordisk Investigational Site

Little Rock, Arkansas, United States

Novo Nordisk Investigational Site

Los Angeles, California, United States

Novo Nordisk Investigational Site

Orange, California, United States

Novo Nordisk Investigational Site

Tampa, Florida, United States

Novo Nordisk Investigational Site

Boston, Massachusetts, United States

Novo Nordisk Investigational Site

Portland, Oregon, United States

Novo Nordisk Investigational Site

Hershey, Pennsylvania, United States

Novo Nordisk Investigational Site

Rio de Janeiro, Brazil

Novo Nordisk Investigational Site

Le Kremlin-Bicêtre, France

Novo Nordisk Investigational Site

Paris, France

Key Dates

Start Date

September 1, 2009

Primary Completion Date

March 29, 2011

Completion Date

March 29, 2011

Last Updated

September 5, 2018

Enrollment

23

ACTUAL participants

Conditions

Congenital Bleeding DisorderHaemophilia A With InhibitorsHaemophilia B With Inhibitors

Interventions

activated recombinant human factor VII, long acting

DRUG

activated recombinant human factor VII, long acting

DRUG

activated recombinant human factor VII, long acting

DRUG

Sponsors

Lead Sponsor

Novo Nordisk A/S

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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