NCT01561924|CompletedPhase 1

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

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

F7HAEM-1675

Study Type

interventional

Target

Locations

4 countries

Sites

Timeline

RegisteredMar 2012

StartedNov 2005

CompletionMay 2006

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_1

Timeline

Completed

Started Nov 2005

Shorter than P25 for phase_1

Geographic Reach

4 countries

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6 months study duration

Study Start

First participant enrolled

November 1, 2005

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed

5.9 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2012

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed

Last Updated

November 23, 2016

Status Verified

November 1, 2016

Enrollment Period

6 months

First QC Date

March 21, 2012

Last Update Submit

November 22, 2016

Conditions

Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors

Outcome Measures

Primary Outcomes (2)

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

Study Arms (1)

Ex vivo

EXPERIMENTAL

Drug: eptacog alfa (activated)

Interventions

eptacog alfa (activated)DRUG

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.

Also known as: activated recombinant human factor VII

Ex vivo

Eligibility Criteria

Age16 Years+

Sexmale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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)

You may not qualify if:

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

Contact the study team to confirm eligibility.