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

This study has been completed.

Sponsor:

Information provided by:

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT01562587

First received: March 22, 2012

Last updated: May 24, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 22, 2012

Last Updated Date

May 24, 2012

Start Date ^ICMJE

September 2002

Primary Completion Date

May 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Area under the concentration curve from 0-12 hours [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01562587 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

CL, the total body clearance [ Designated as safety issue: No ]
Cmax, the maximum concentration [ Designated as safety issue: No ]
tmax, the time to maximum concentration [ Designated as safety issue: No ]
t1/2, the terminal half-life [ Designated as safety issue: No ]
Area under the concentration curve from time 0-infinity [ Designated as safety issue: No ]
Vss, the apparent volume of distribution at steady state [ Designated as safety issue: No ]
Adverse events [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Congenital Bleeding Disorder
Haemophilia A
Haemophilia B

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Adults
Intervention: Drug: activated recombinant human factor VII
Experimental: Paediatric
Intervention: Drug: activated recombinant human factor VII

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2003

Primary Completion Date

May 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

3 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany, Greece, Italy, Spain, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01562587

Other Study ID Numbers ^ICMJE

F7HAEM-1503

Has Data Monitoring Committee

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Peter B. Schelde, MSc

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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