Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non- Bleeding State

January 11, 2017 updated by: Novo Nordisk A/S

Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non-Bleeding State

This trial is conducted in Europe. The aim of this trial is to determine the pharmacokinetics of activated recombinant human factor VII (NovoSeven®) in haemophiliac patients in a non-bleeding state.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

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

  • Germany
      • Bremen, Germany, 28205
        • Novo Nordisk Investigational Site
      • Frankfurt, Germany, 60590
        • Novo Nordisk Investigational Site
  • Greece
      • Athens, Greece, GR-11527
        • Novo Nordisk Investigational Site
  • Italy
      • Firenze, Italy, 50134
        • Novo Nordisk Investigational Site
      • Milano, Italy, 20124
        • Novo Nordisk Investigational Site
  • Spain
      • Madrid, Spain, 28046
        • Novo Nordisk Investigational Site
  • United Kingdom
      • London, United Kingdom, WC1N 3JH
        • Novo Nordisk Investigational Site
      • Oxford, United Kingdom, OX3 7LJ
        • 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

3 years to 55 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Age 18-55 years and congenital haemophilia A or B male with severe FVIII or FX deficiency +/-inhibitors
  • Age between 3-12 years and congenital haemophilia A or B male with record of inhibitors

Exclusion Criteria:

  • Known hypersensitivity to activated recombinant human factor VII or any of its components
  • Known clinical relevant coagulation diseases or insufficiencies other than congenital haemophilia
  • Clinical manifestation of HIV (human immunodeficiency virus) and/or protease inhibitor treatment
  • Clinical manifestation of active/recent bleeding
  • Administration of coagulation factor preparations within 24 hours of NovoSeven trial product dose administration
  • Body Mass Index (BMI) outside normal range
  • Known abuse of elicit drugs and/or alcohol
  • Renal insufficiency
  • Hepatic disease
  • Cardiovascular disease
  • Any disease or condition which, judged by the Investigator, could imply a potential hazard to the patient, interfere with the trial participation or trial outcome

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Adults
Drug: activated recombinant human factor VII
A single bolus dose is administered. Injected intravenously
Drug: activated recombinant human factor VII
A random order of a low/high dose of single dose is administered during two PK-assessment periods separated by a washout period of 48 hours to one month. Injected intravenously
EXPERIMENTAL: Paediatric
Drug: activated recombinant human factor VII
A single bolus dose is administered. Injected intravenously
Drug: activated recombinant human factor VII
A random order of a low/high dose of single dose is administered during two PK-assessment periods separated by a washout period of 48 hours to one month. Injected intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Area under the concentration curve from 0-12 hours

Secondary Outcome Measures

Outcome Measure
Adverse events
CL, the total body clearance
Cmax, the maximum concentration
tmax, the time to maximum concentration
t1/2, the terminal half-life
Area under the concentration curve from time 0-infinity
Vss, the apparent volume of distribution at steady state

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.

General Publications

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

September 1, 2002

Primary Completion (ACTUAL)

May 1, 2003

Study Completion (ACTUAL)

May 1, 2003

Study Registration Dates

First Submitted

March 22, 2012

First Submitted That Met QC Criteria

March 23, 2012

First Posted (ESTIMATE)

March 26, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F7HAEM-1503

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.

Clinical Trials on Congenital Bleeding Disorder

Clinical Trials on activated recombinant human factor VII

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe