Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non- Bleeding State
Launched by NOVO NORDISK A/S · Mar 23, 2012
Trial Information
Current as of May 24, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
MALE
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
About Novo Nordisk A/S
Novo Nordisk A/S is a global healthcare company headquartered in Denmark, specializing in the research, development, manufacturing, and marketing of innovative pharmaceuticals, particularly in the fields of diabetes care, obesity treatment, and hormone replacement therapies. With a strong commitment to improving patient outcomes, Novo Nordisk invests significantly in clinical trials to advance scientific knowledge and develop effective therapies. The company is dedicated to sustainability and ethical practices, striving to deliver high-quality healthcare solutions while addressing the evolving needs of patients worldwide. Through collaboration and innovation, Novo Nordisk aims to lead the way in transforming diabetes and other chronic diseases into manageable conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Madrid, , Spain
Firenze, , Italy
Frankfurt, , Germany
Athens, , Greece
Milano, , Italy
Oxford, , United Kingdom
London, , United Kingdom
Bremen, , Germany
Patients applied
Trial Officials
Global Clinical Registry (GCR, 1452)
Study Director
Novo Nordisk A/S
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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