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

Phase 1

Completed

• Conditions: Congenital Bleeding Disorder; Haemophilia A; Haemophilia B
• Interventions: Drug: activated recombinant human factor VII

• Registration Number: NCT01562587
• Lead Sponsor: Novo Nordisk A/S

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 available

Study Timeline

• Study Start: 2002-09
• Primary Completion: 2003-05
• Study Completion: 2003-05
• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-03-23
• Study First Posted: 2012-03-26
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adults	activated recombinant human factor VII	-
Paediatric	activated recombinant human factor VII	-

Primary Outcome Measures

Name	Time	Method
Area under the concentration curve from 0-12 hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Oxford, United Kingdom