NCT01563471

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics of three different single doses activated recombinant human factor VII in Caucasian and Japanese healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2001

Geographic Reach
1 country

1 active site

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

October 1, 2001

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2002

Completed
9.7 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2012

Completed
Last Updated

January 13, 2017

Status Verified

January 1, 2017

Enrollment Period

9 months

First QC Date

March 23, 2012

Last Update Submit

January 12, 2017

Conditions

Congenital Bleeding DisorderHaemophilia A With InhibitorsHaemophilia B With InhibitorsHealthy

Outcome Measures

Primary Outcomes (1)

  • Area under the Curve (AUC) of FVII:C (Factor VII clotting activity) from 0-24 hours

Secondary Outcomes (5)

  • Mean residence time (MRT)

  • Maximum plasma concentration (Cmax)

  • Time to reach maximum plasma concentration (tmax)

  • Area under the Curve (AUC) from 0-24 hours of the PT (Prothrombin Time)

  • Adverse events

Study Arms (4)

Treatment sequence 1

EXPERIMENTAL
Drug: activated recombinant human factor VIIDrug: placebo

Treatment sequence 2

EXPERIMENTAL
Drug: activated recombinant human factor VIIDrug: placebo

Treatment sequence 3

EXPERIMENTAL
Drug: activated recombinant human factor VIIDrug: placebo

Treatment sequence 4

PLACEBO COMPARATOR
Drug: activated recombinant human factor VIIDrug: placebo

Interventions

activated recombinant human factor VIIDRUG

Subjects will be randomised to one of four treatment sequences. Subjects will receive single bolus i.v. injection of 40, 80 or 160 mcg/kg body weight of trial drug or placebo on each day of the three separate visits

Treatment sequence 1Treatment sequence 2Treatment sequence 3Treatment sequence 4
placeboDRUG

Subjects will be randomised to one of four treatment sequences. Subjects will receive single bolus i.v. injection of 40, 80 or 160 mcg/kg body weight of trial drug or placebo on each day of the three separate visits

Treatment sequence 1Treatment sequence 2Treatment sequence 3Treatment sequence 4

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Caucasian or Japanese
  • Healthy as defined by medical history, physical and biological examinations

You may not qualify if:

  • History of allergy or hypersensitivity reaction to any medication
  • History or presence of any organic disorder likely to modify absorption, distribution or elimination of the medication
  • Alcohol or substance abuse disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Paris, 75015, France

Location

Related Publications (2)

  • Fridberg MJ, Hedner U, Roberts HR, Erhardtsen E. A study of the pharmacokinetics and safety of recombinant activated factor VII in healthy Caucasian and Japanese subjects. Blood Coagul Fibrinolysis. 2005 Jun;16(4):259-66. doi: 10.1097/01.mbc.0000169218.15926.34.

    PMID: 15870545RESULT

  • Levy JH, Fingerhut A, Brott T, Langbakke IH, Erhardtsen E, Porte RJ. Recombinant factor VIIa in patients with coagulopathy secondary to anticoagulant therapy, cirrhosis, or severe traumatic injury: review of safety profile. Transfusion. 2006 Jun;46(6):919-33. doi: 10.1111/j.1537-2995.2006.00824.x.

    PMID: 16734808RESULT

Related Links

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2012

First Posted

March 27, 2012

Study Start

October 1, 2001

Primary Completion

July 1, 2002

Study Completion

July 1, 2002

Last Updated

January 13, 2017

Record last verified: 2017-01

Locations

FR(1)