NCT01562457

Brief Summary

This trial is conducted in Asia and Europe. The aim of this trial is to evaluate the intra-subject variability of thromboelastographic parameters (TEG® and ROTEM®) following two administrations of activated recombinant human factor VII in haemophilia patients in a non bleeding state. 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).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_1

Geographic Reach
3 countries

3 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

Study Start

First participant enrolled

November 1, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
6 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

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

5 months

First QC Date

March 21, 2012

Last Update Submit

May 11, 2016

Conditions

Congenital Bleeding DisorderHaemophilia AHaemophilia B

Outcome Measures

Primary Outcomes (2)

  • TEG® (Thromboelastography) parameters after dosing of trial product

  • ROTEM® (Thromboelastometry) parameters after dosing of trial product

Secondary Outcomes (3)

  • TEG® parameters obtained from blood samples spiked ex vivo with activated recombinant human factor VII

  • ROTEM® parameters obtained from blood samples spiked ex vivo with activated recombinant human factor VII

  • Serious adverse events and non-serious adverse events

Study Arms (3)

Low dose

EXPERIMENTAL
Drug: activated recombinant human factor VII

Medium dose

EXPERIMENTAL
Drug: activated recombinant human factor VII

High dose

EXPERIMENTAL
Drug: activated recombinant human factor VII

Interventions

activated recombinant human factor VIIDRUG

Administered as a single dose. Injected as a slow intravenous injection over 2 minutes (from start to completion of injection)

High doseLow doseMedium dose

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 (Activated Coagulation Factor VIIa Clotting activity) or FIX:C (Coagulation Factor IX Clotting activity) one stage activity, respectively, at less than 5% of normal (based on medical records) plus/minus inhibitors (a positive inhibitor status defined as 0.6 Bethesda units)
  • Non-bleeding state (i.e. no clinical manifestation of active bleed) at the time of administration of trial product

You may not qualify if:

  • Known or suspected allergy to trial product or any of its components or to related products
  • Known clinically relevant coagulation disorders or insufficiencies other than congenital haemophilia A or B
  • Platelet count below 50,000 platelets/mcL
  • Received any haemostatic treatment (e.g. Feiba) within the last 7 days prior to administration of trial product, except for activated recombinant human factor VII

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Lille, 59037, France

Location

Unknown Facility

München, 80336, Germany

Location

Unknown Facility

Tel Litwinsky, 52621, Israel

Location

Related Links

MeSH Terms

Conditions

Hemophilia AHemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-Linked

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2012

First Posted

March 23, 2012

Study Start

November 1, 2005

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

IL(1)FR(1)DE(1)