Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773
NCT ID: NCT01395810
Last Updated: 2018-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
71 participants
INTERVENTIONAL
2012-04-15
2014-03-30
Brief Summary
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This trial is an extension to trials NN7999-3747 (NCT01333111/paradigm™ 2) and NN7999-3773 (NCT01386528/paradigm™ 3).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prophylaxis, high dose (once weekly)
nonacog beta pegol
One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience.
Prophylaxis, low dose (once weekly)
nonacog beta pegol
One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience.
On-demand
nonacog beta pegol
One single dose administered intravenously (into the vein). Patients will treat themselves with either a low or a high dose dependent on the severity of the bleeding episode.
Prophylaxis, high dose (every second week)
nonacog beta pegol
One single dose administered intravenously (into the vein) every second week. Patients will receive instruction on how to treat any bleeding episode they may experience.
Interventions
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nonacog beta pegol
One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience.
nonacog beta pegol
One single dose administered intravenously (into the vein). Patients will treat themselves with either a low or a high dose dependent on the severity of the bleeding episode.
nonacog beta pegol
One single dose administered intravenously (into the vein) every second week. Patients will receive instruction on how to treat any bleeding episode they may experience.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Current FIX inhibitors above or equal to 0.6 BU (Bethesda Units)
* Congenital or acquired coagulation disorders other than haemophilia B
* 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)
* Any disease (liver, kidney, inflammatory and mental disorders included) or condition which, according to the Investigator's (trial physician) judgement, could imply a potential hazard to the patient, interfere with trial participation, or interfere with trial outcome
13 Years
70 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
Los Angeles, California, United States
Novo Nordisk Investigational Site
San Francisco, California, United States
Novo Nordisk Investigational Site
Washington D.C., District of Columbia, United States
Novo Nordisk Investigational Site
Jacksonville, Florida, United States
Novo Nordisk Investigational Site
Augusta, Georgia, United States
Novo Nordisk Investigational Site
Iowa City, Iowa, United States
Novo Nordisk Investigational Site
Baltimore, Maryland, United States
Novo Nordisk Investigational Site
Minneapolis, Minnesota, United States
Novo Nordisk Investigational Site
Omaha, Nebraska, United States
Novo Nordisk Investigational Site
Newark, New Jersey, United States
Novo Nordisk Investigational Site
New York, New York, United States
Novo Nordisk Investigational Site
Syracuse, New York, United States
Novo Nordisk Investigational Site
Houston, Texas, United States
Novo Nordisk Investigational Site
Vienna, , Austria
Novo Nordisk Investigational Site
Bron, , France
Novo Nordisk Investigational Site
Le Kremlin-Bicêtre, , France
Novo Nordisk Investigational Site
Bonn, , Germany
Novo Nordisk Investigational Site
Duisburg, , Germany
Novo Nordisk Investigational Site
Giessen, , Germany
Novo Nordisk Investigational Site
Hanover, , Germany
Novo Nordisk Investigational Site
Athens, , Greece
Novo Nordisk Investigational Site
Florence, , Italy
Novo Nordisk Investigational Site
Milan, , Italy
Novo Nordisk Investigational Site
Kashihara-shi, Nara, , Japan
Novo Nordisk Investigational Site
Kawasaki-shi, Kanagawa, , Japan
Novo Nordisk Investigational Site
Nagoya-shi, Aichi, , Japan
Novo Nordisk Investigational Site
Nishinomiya-shi, , Japan
Novo Nordisk Investigational Site
Shinjuku-ku, Tokyo, , Japan
Novo Nordisk Investigational Site
Suginami-ku, Tokyo, , Japan
Novo Nordisk Investigational Site
Kuala Lumpur, , Malaysia
Novo Nordisk Investigational Site
Utrecht, , Netherlands
Novo Nordisk Investigational Site
Skopje, , North Macedonia
Novo Nordisk Investigational Site
Timișoara, Timiș County, Romania
Novo Nordisk Investigational Site
Moscow, , Russia
Novo Nordisk Investigational Site
Saint Petersburg, , Russia
Novo Nordisk Investigational Site
Parktown Johannesburg, Gauteng, South Africa
Novo Nordisk Investigational Site
Madrid, , Spain
Novo Nordisk Investigational Site
Valencia, , Spain
Novo Nordisk Investigational Site
Taipei, , Taiwan
Novo Nordisk Investigational Site
Bangkok, , Thailand
Novo Nordisk Investigational Site
Ankara, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Kayseri, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Konya, , 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
Manchester, , United Kingdom
Novo Nordisk Investigational Site
Oxford, , United Kingdom
Countries
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References
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Young G, Collins P, Tehranchi R, Chuansumrit A, Hanabusa H, Lentz SR, Mahlangu J, Mauser-Bunschoten E, Negrier C, Oldenburg J, Patiroglu T, Santagostino E, Zak M, Abdul Karim F. Safety and efficacy of nonacog beta pegol (N9-GP) for prophylaxis and treatment of bleeding episodes in previously-treated patients with hemophilia B: results from an extension trial. American Society of Hematology - 56th Annual Meeting (ASH) in San Francisco, CA, US
Young G, Collins PW, Colberg T, Chuansumrit A, Hanabusa H, Lentz SR, Mahlangu J, Mauser-Bunschoten EP, Negrier C, Oldenburg J, Patiroglu T, Santagostino E, Tehranchi R, Zak M, Karim FA. Nonacog beta pegol (N9-GP) in haemophilia B: A multinational phase III safety and efficacy extension trial (paradigm4). Thromb Res. 2016 May;141:69-76. doi: 10.1016/j.thromres.2016.02.030. Epub 2016 Mar 2.
Chowdary P, Kearney S, Regnault A, Hoxer CS, Yee DL. Improvement in health-related quality of life in patients with haemophilia B treated with nonacog beta pegol, a new extended half-life recombinant FIX product. Haemophilia. 2016 Jul;22(4):e267-74. doi: 10.1111/hae.12995. Epub 2016 Jun 28.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2010-023072-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1121-5408
Identifier Type: OTHER
Identifier Source: secondary_id
JapicCTI-121812
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN7999-3775
Identifier Type: -
Identifier Source: org_study_id
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