Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With Inhibitors
NCT ID: NCT00951405
Last Updated: 2018-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
23 participants
INTERVENTIONAL
2009-09-01
2011-03-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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A
activated recombinant human factor VII, long acting
After an observation period of 3 months, every 2nd day intravenous (i.v.) injection with 25 microgrammes/kg activated recombinant human factor VII, long acting, for 3 months
B
activated recombinant human factor VII, long acting
After an observation period of 3 months, every 2nd day intravenous (i.v.) injection with 100 microgrammes/kg activated recombinant human factor VII, long acting, for 3 months
C
activated recombinant human factor VII, long acting
After an observation period of 3 months, every 2nd day intravenous (i.v.) injection with 200 microgrammes/kg activated recombinant human factor VII, long acting, for 3 months
Interventions
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activated recombinant human factor VII, long acting
After an observation period of 3 months, every 2nd day intravenous (i.v.) injection with 25 microgrammes/kg activated recombinant human factor VII, long acting, for 3 months
activated recombinant human factor VII, long acting
After an observation period of 3 months, every 2nd day intravenous (i.v.) injection with 100 microgrammes/kg activated recombinant human factor VII, long acting, for 3 months
activated recombinant human factor VII, long acting
After an observation period of 3 months, every 2nd day intravenous (i.v.) injection with 200 microgrammes/kg activated recombinant human factor VII, long acting, for 3 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing to undergo a bleeding preventive regimen of 3 months' duration and a total trial length of approximately 8 months
* Historical or ongoing high titre inhibitor (more than or equal to 5 BU) based on either medical records, laboratory report reviews, patient and/or care provider interviews
* At least 2 bleeding episodes requiring bypassing haemostatic-drug-based treatment within the last month or 12 bleeding episodes within the last 6 months prior to observation period
* Body weight between 30 and 100 kg (both inclusive)
Exclusion Criteria
* Immune tolerance induction therapy within the last month prior to entering observation phase period
* Known active pseudo tumours
* Platelet count less than 50,000 platelets/microL (based on local laboratory value at screening visit)
* Congenital or acquired coagulation disorders other than haemophilia A or B
* Surgery within one month prior to the observation period. Catheter, stents and dental extractions do not count as surgeries, i.e. they will not exclude the patient. Port insertion is classified as surgery
* Scheduled major and/or orthopaedic surgery, during the trial period until Follow up visit. Catheter, stents and dental extractions do not count as surgeries and will not exclude the patient. Port insertion is classified as surgery
* Advanced atherosclerotic disease (i.e. known history of ischemic heart disease, or ischemic stroke)
* Any clinical signs or known history of thromboembolic events incl. known deep vein thrombosis (DVT)
* Known or clinically suspected allergy to activated recombinant human factor VII (NovoSeven®/NovoSeven RT®/Niastase®)
* Prothrombin Time (PT) prolongation (30% above normal limits, or more than 5 seconds compared to control or International Normalised Range (INR) more than 1.7 as defined by local laboratory ranges at screening visit
* Severe liver disease (ALAT more than 4 times of the upper limit of normal reference range) (as defined by local laboratory ranges) within a year of enrolment or at the screening
* Clinical signs of renal dysfunction (dialysis) and/or creatinine levels more than or equal to 20% above upper normal limit (according to local laboratory range at the screening visit)
* Dosing of any investigational drug within the last 30 days prior to the present trial
* Any disease or condition which, according to the investigator's judgement, could imply a potential hazard to the subject, interfere with the trial participation or trial outcome
* HIV positive patients who either have low CD4+ lymphocyte count ( 200/microL or less based on medical records within 6 months or laboratory screening at screening visit), or who are HCV-PCR positive (based on medical records), or who both have low CD4+ lymphocyte count (200/microL or less) and are HCV-PCR positive. If HCV-PCR testing is not locally available, a HIV positive patient who is HCV antibody positive cannot be included
* Need to use other PEGylated pharmaceutical drug during the trial period
12 Years
65 Years
MALE
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Little Rock, Arkansas, United States
Novo Nordisk Investigational Site
Los Angeles, California, United States
Novo Nordisk Investigational Site
Orange, California, United States
Novo Nordisk Investigational Site
Tampa, Florida, United States
Novo Nordisk Investigational Site
Boston, Massachusetts, United States
Novo Nordisk Investigational Site
Portland, Oregon, United States
Novo Nordisk Investigational Site
Hershey, Pennsylvania, United States
Novo Nordisk Investigational Site
Rio de Janeiro, , Brazil
Novo Nordisk Investigational Site
Le Kremlin-Bicêtre, , France
Novo Nordisk Investigational Site
Paris, , France
Novo Nordisk Investigational Site
Kashihara-shi, Nara, , Japan
Novo Nordisk Investigational Site
Kitakyusyu, Fukuoka, , Japan
Novo Nordisk Investigational Site
Nishinomiya-shi, , Japan
Novo Nordisk Investigational Site
Shinjuku-ku, Tokyo, , Japan
Novo Nordisk Investigational Site
Kuala Lumpur, , Malaysia
Novo Nordisk Investigational Site
Belgrade, , Serbia and Montenegro
Novo Nordisk Investigational Site
Belgrade, , Serbia
Novo Nordisk Investigational Site
Parktown Johannesburg, Gauteng, South Africa
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa
Novo Nordisk Investigational Site
Malmo, , Sweden
Novo Nordisk Investigational Site
Ankara, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Istanbul, , Turkey (Türkiye)
Novo Nordisk Investigational Site
London, , United Kingdom
Novo Nordisk Investigational Site
London, , United Kingdom
Novo Nordisk Investigational Site
Oxford, , United Kingdom
Countries
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References
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Ljung R, Karim FA, Saxena K, Suzuki T, Arkhammar P, Rosholm A, Giangrande P; Pioneer1 Investigators. 40K glycoPEGylated, recombinant FVIIa: 3-month, double-blind, randomized trial of safety, pharmacokinetics and preliminary efficacy in hemophilia patients with inhibitors. J Thromb Haemost. 2013 Jul;11(7):1260-8. doi: 10.1111/jth.12237.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2008-006424-54
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
JapicCTI-090860
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1111-8584
Identifier Type: OTHER
Identifier Source: secondary_id
NN7128-1907
Identifier Type: -
Identifier Source: org_study_id
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