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
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Area under the concentration curve from 0-12 hours
Secondary Outcome
CL, the total body clearance
Condition
Congenital Bleeding Disorder
Intervention
activated recombinant human factor VII
Study Arms / Comparison Groups
Adults
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
18
Start Date
September 2002
Completion Date
May 2003
Primary Completion Date
May 2003
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
Gender
Male
Ages
3 Years - 55 Years
Accepts Healthy Volunteers
No
Contacts
Global Clinical Registry (GCR, 1452), ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT01562587
Organization ID
F7HAEM-1503
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S
Verification Date
January 2017