Evaluating the Haemostatic Effect of NNC 0129-0000-1003 During Surgical Procedures in Subjects With Haemophilia A.
NCT ID: NCT01489111
Last Updated: 2020-08-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
36 participants
INTERVENTIONAL
2012-08-03
2018-12-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Surgery
turoctocog alfa pegol
Bleeding preventive treatment administered i.v. before, during and after surgery. Individually adjusted doses.
Interventions
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turoctocog alfa pegol
Bleeding preventive treatment administered i.v. before, during and after surgery. Individually adjusted doses.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ongoing participation in the pathfinder™2 (NN7088-3859) or the pathfinderTM 4 (NN7088-3861) trial and having received greater than or equal to 5 doses of N8-GP
* Undergoing major surgery requiring daily monitoring of FVIII:C (FVIII activity) and wound status for at least 3 days
* The patient and/or Legally Acceptable Representative (LAR) is capable of assessing a bleeding episode, keeping an eDiary, capable of home treatment of bleeding episodes and otherwise capable of following the trial procedures
Exclusion Criteria
* Previous withdrawal from the pathfinder™2 (NN7088-3859) or the pathfinderTM 4 (NN7088-3861) trial after administration of trial product, except interruption due to inclusion in this pathfinderTM 3 trial (NN7088-3860)
* The receipt of any investigational medicinal product (except N8-GP) within 30 days prior to enrolment into the trial. (For Brazil, only: Participation in a previous clinical trial within one year prior to screening for this trial (Visit 1), unless there is a direct benefit to the research subject, at the Investigator's discretion)
* FVIII inhibitors at least 0.6 BU (Bethesda Units)/mL at screening
* Previous arterial thrombotic events (e.g. myocardial infarction and intracranial thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by available medical records)
* Immune modulating or chemotherapeutic medication
* Any disease (liver, kidney, inflammatory and mental disorders included) or condition which, according to the Investigator's judgement, could imply a potential hazard to the patient, interfere with trial participation or trial outcome
* Unwillingness, language or other barriers precluding adequate understanding and/or cooperation
12 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
Phoenix, Arizona, United States
Novo Nordisk Investigational Site
Long Beach, California, United States
Novo Nordisk Investigational Site
Sacramento, California, United States
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Torrance, California, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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Boise, Idaho, United States
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Iowa City, Iowa, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Newark, New Jersey, United States
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Cincinnati, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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Norfolk, Virginia, United States
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Spokane, Washington, United States
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Camperdown, New South Wales, Australia
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South Brisbane, Queensland, Australia
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Parkville, Victoria, Australia
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Campinas, São Paulo, Brazil
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Sofia, , Bulgaria
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Split, , Croatia
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Zagreb, , Croatia
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Århus N, , Denmark
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København Ø, , Denmark
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Bron, , France
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Le Kremlin-Bicêtre, , France
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Nantes, , France
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Paris, , France
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Berlin, , Germany
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Bonn, , Germany
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Frankfurt/M., , Germany
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Hanover, , Germany
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Homburg, , Germany
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München, , Germany
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Budapest, , Hungary
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Debrecen, , Hungary
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Tel Litwinsky, , Israel
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Milan, , Italy
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Udine, , Italy
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Vicenza, , Italy
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Kashihara-shi, Nara, , Japan
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Shinjuku-ku, Tokyo, , Japan
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Suginami-ku, Tokyo, , Japan
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Tokyo, , Japan
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Kuala Lumpur, , Malaysia
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Selangor Darul Ehsan, , Malaysia
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Groningen, , Netherlands
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Rotterdam, , Netherlands
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Oslo, , Norway
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Madrid, , Spain
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Málaga, , Spain
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Malmo, , Sweden
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Geneva, , Switzerland
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Lausanne, , Switzerland
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Zurich, , Switzerland
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Changhua, , Taiwan
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Taipei, , Taiwan
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Adana, , Turkey (Türkiye)
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Bornova-IZMIR, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Samsun, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Basingstoke, , United Kingdom
Novo Nordisk Investigational Site
Cardiff, , United Kingdom
Novo Nordisk Investigational Site
London, , United Kingdom
Novo Nordisk Investigational Site
London, , United Kingdom
Novo Nordisk Investigational Site
Oxford, , United Kingdom
Novo Nordisk Investigational Site
Sheffield, , United Kingdom
Countries
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References
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Tosetto A, Neff A, Lentz SR, Santagostino E, Nemes L, Sathar J, Meijer K, Chowdary P, Shen C, Landorph A, Hampton K. Turoctocog alfa pegol provides effective management for major and minor surgical procedures in patients across all age groups with severe haemophilia A: Full data set from the pathfinder 3 and 5 phase III trials. Haemophilia. 2020 May;26(3):450-458. doi: 10.1111/hae.13980. Epub 2020 Apr 15.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1119-7326
Identifier Type: OTHER
Identifier Source: secondary_id
2011-001144-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
132215
Identifier Type: OTHER
Identifier Source: secondary_id
NN7088-3860
Identifier Type: -
Identifier Source: org_study_id
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