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Prediction of the Efficacy of Activated Recombinant Human Factor VII in Adult Congenital Haemophilia A or B Patients With Inhibitors by Use of Thromboelastography | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Prediction of the Efficacy of Activated Recombinant Human Factor VII in Adult Congenital Haemophilia A or B Patients With Inhibitors by Use of Thromboelastography

An Exploratory Non-interventional Study of Ex-vivo Spiking Followed by Thromboelastography as a Method for Predicting the Efficacy of Recombinant Activated Human FVII (rFVIIa, NovoSeven®) in Adult Congenital Haemophilia A or B Patients With Inhibitors

NCT01561924•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the basal and spiked TEG® (Thromboelastography) or ROTEM® (Thromboelastometry) profiles of frequently bleeding haemophilia subjects with inhibitors in a non-bleeding state.

Detailed Description

The TEG parameters are: R time (Reaction Time), K time (K Time (arbitrary measurement)), a (a angle), MA (Maximum Amplitude) and LY30 (Lysis 30 min after MA) while the ROTEM parameters are: CT (Clotting Time), CFT (Clot Formation Time), a (a angle), MCF (Maximum Clot Firmness) and LI60 (Lysis index 60 min after CT)

Eligibility

Age

16 - No limit years

Sex

MALE

Healthy Volunteers

No

Inclusion Criteria

•Confirmed diagnosis of congenital haemophilia A or B with a FVIII:C clot activity or FIX:C clot activity, respectively, less than 5%
•Presently use of activated recombinant human factor VII (NovoSeven®) as haemostatic agent for preventive treatment or treatment of bleeding episodes
•A documented historical or present record for the presence of inhibitors to factor VIII or IX, respectively
•A documented history of 2 or more joint bleeding episodes during the preceding 12 months
•Subjects must be in a non-bleeding state (i.e. no clinical manifestations of active bleeds)

Exclusion Criteria

•Subjects who have received any haemostatic treatment for a bleeding episode within the last 7 days prior to this trial
•Immune tolerance therapy within the last 30 days prior to this trial
•Clinically relevant coagulation disorders other than congenital haemophilia A or B
•Thrombocytopenia (platelet count below 60,000 platelets/mcl)
•Prophylactic haemostatic treatment within 3 days prior to this trial

Locations (7)

Novo Nordisk Investigational Site

Berkeley, California, United States

Novo Nordisk Investigational Site

Los Angeles, California, United States

Novo Nordisk Investigational Site

Iowa City, Iowa, United States

Novo Nordisk Investigational Site

Philadelphia, Pennsylvania, United States

Novo Nordisk Investigational Site

Århus N, Denmark

Novo Nordisk Investigational Site

Lyon, France

Novo Nordisk Investigational Site

London, United Kingdom

Key Dates

Start Date

November 1, 2005

Primary Completion Date

May 1, 2006

Completion Date

May 1, 2006

Last Updated

November 23, 2016

Enrollment

17

ACTUAL participants

Conditions

Congenital Bleeding DisorderHaemophilia A With InhibitorsHaemophilia B With Inhibitors

Interventions

eptacog alfa (activated)

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: November 23, 2016Data 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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