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

Primary Purpose

Congenital Bleeding Disorder, Haemophilia A, Haemophilia B

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
activated recombinant human factor VII
activated recombinant human factor VII
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Bleeding Disorder

Eligibility Criteria

3 Years - 55 Years (Child, Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Adults

Paediatric

Arm Description

Outcomes

Primary Outcome Measures

Area under the concentration curve from 0-12 hours

Secondary Outcome Measures

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
Adverse events

Full Information

First Posted
March 22, 2012
Last Updated
January 11, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01562587
Brief Title
Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non- Bleeding State
Official Title
Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non-Bleeding State
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
May 2003 (Actual)
Study Completion Date
May 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Bleeding Disorder, Haemophilia A, Haemophilia B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adults
Arm Type
Experimental
Arm Title
Paediatric
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
activated recombinant human factor VII
Intervention Description
A single bolus dose is administered. Injected intravenously
Intervention Type
Drug
Intervention Name(s)
activated recombinant human factor VII
Intervention Description
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
Primary Outcome Measure Information:
Title
Area under the concentration curve from 0-12 hours
Secondary Outcome Measure Information:
Title
CL, the total body clearance
Title
Cmax, the maximum concentration
Title
tmax, the time to maximum concentration
Title
t1/2, the terminal half-life
Title
Area under the concentration curve from time 0-infinity
Title
Vss, the apparent volume of distribution at steady state
Title
Adverse events

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Bremen
ZIP/Postal Code
28205
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
GR-11527
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Milano
ZIP/Postal Code
20124
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
15230949
Citation
Villar A, Aronis S, Morfini M, Santagostino E, Auerswald G, Thomsen HF, Erhardtsen E, Giangrande PL. Pharmacokinetics of activated recombinant coagulation factor VII (NovoSeven) in children vs. adults with haemophilia A. Haemophilia. 2004 Jul;10(4):352-9. doi: 10.1111/j.1365-2516.2004.00925.x.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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