Status:
COMPLETED
Evaluation of Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Subjects With Haemophilia A
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Congenital Bleeding Disorder
Haemophilia A
Eligibility:
MALE
12+ years
Phase:
PHASE3
Brief Summary
This trial is conducted globally. The aim of the trial is to evaluate the safety and efficacy, including pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in ...
Eligibility Criteria
Inclusion
- Male patients with severe congenital haemophilia A (FVIII activity below 1%, according to medical records) - Documented history of at least 150 EDs (exposure days) to other FVIII products - At least 12 years and body weight at least 35 kg (except for Croatia, France, Russia, Israel and the Netherlands where the lower age limit will be 18 years)
Exclusion
- Previous participation in this trial defined as withdrawal after administration N8-GP - Any history of FVIII inhibitors - FVIII inhibitors above or equal to 0.6 BU/mL at screening - HIV (human immunodeficiency virus) positive, defined by medical records with CD4+ (T-lymphocyte subtype) count below or equal to 200/mcL or a viral load of more than 400000 copies/mL. If the data is not available in medical records within last 6 months, CD4+ will be measured at the screening visit - Congenital or acquired coagulation disorders other than haemophilia A - Previous significant thromboembolic events (e.g. myocardial infarction, cerebrovascular disease or deep venous thrombosis) as defined by available medical records - Platelet count below 50,000 platelets/mcL (laboratory value at the screening visit) - ALAT (alanine aminotransferase) above 3 times the upper limit of normal reference ranges at central laboratory - Creatinine level equal to or greater than 1.5 times above upper normal limit (according to central laboratory reference ranges) - Ongoing immune modulating or chemotherapeutic medication
Key Trial Info
Start Date :
January 30 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2018
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT01480180
Start Date
January 30 2012
End Date
December 10 2018
Last Update
November 23 2020
Active Locations (93)
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1
Novo Nordisk Investigational Site
Phoenix, Arizona, United States, 85016
2
Novo Nordisk Investigational Site
Long Beach, California, United States, 90806
3
Novo Nordisk Investigational Site
Sacramento, California, United States, 95817
4
Novo Nordisk Investigational Site
Torrance, California, United States, 90502-2004