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

November 22, 2016 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Århus N, Denmark, 8200
        • Novo Nordisk Investigational Site
  • France
      • Lyon, France, 69003
        • Novo Nordisk Investigational Site
  • United Kingdom
      • London, United Kingdom, E1 2AD
        • Novo Nordisk Investigational Site
  • United States
    • California
      • Berkeley, California, United States, 94704
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90027
        • Novo Nordisk Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ex vivo
Drug: eptacog alfa (activated)
Subjects will be called to attend the clinic in a non-bleeding state. Blood samples will be drawn for thromboelastogram profiling and will be in-vitro spiked with different doses of activatated recombinant human factor VII.
Other Names:
  • activated recombinant human factor VII

What is the study measuring?

Primary Outcome Measures

Outcome Measure
TEG parameters obtained at baseline and with activated recombinant human factor VII
ROTEM parameters obtained at baseline and with activated recombinant human factor VII

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

March 21, 2012

First Submitted That Met QC Criteria

March 22, 2012

First Posted (Estimate)

March 23, 2012

Study Record Updates

Last Update Posted (Estimate)

November 23, 2016

Last Update Submitted That Met QC Criteria

November 22, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F7HAEM-1675

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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