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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 (paradigm™ 4)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01395810
First received: June 30, 2011
Last updated: November 10, 2016
Last verified: November 2016
  Purpose

This trial is conducted in Asia, Europe, Japan, North America and South Africa. The aim is to evaluate the safety and efficacy of nonacog beta pegol (NNC-0156-0000-0009) after long-term exposure in patients with haemophilia B.

This trial is an extension to trials NN7999-3747 (NCT01333111/paradigm™ 2) and NN7999-3773 (NCT01386528/paradigm™ 3).


Condition Intervention Phase
Congenital Bleeding Disorder
Haemophilia B
Drug: nonacog beta pegol
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Incidence of inhibitory antibodies against FIX defined as titre above or equal to 0.6 BU (Bethesda Units) [ Time Frame: Every 3rd month the first year of trial, then every 6 months until trial completion (up to 2 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Haemostatic effect of NNC-0156-0000-0009 when used for treatment of bleeding episodes, assessed as success/failure based on a four-point scale for haemostatic response (excellent, good moderate, poor) [ Time Frame: Every 3rd month the first year of trial, then every 6 months until trial completion (up to 2 years) ] [ Designated as safety issue: No ]
  • Number of bleeding episodes during routine prophylaxis [ Time Frame: Every 3rd month the first year of trial, then every 6 months until trial completion (up to 2 years) ] [ Designated as safety issue: No ]
  • FIX trough levels [ Time Frame: Every 3rd month the first year of trial, then every 6 months until trial completion (up to 2 years) ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events (AEs) [ Time Frame: Every 3rd month the first year of trial, then every 6 months until trial completion (up to 2 years) ] [ Designated as safety issue: No ]
  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: Every 3rd month the first year of trial, then every 6 months until trial completion (up to 2 years) ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: April 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prophylaxis, high dose (once weekly) Drug: 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.
Other Name: NNC-0156-0000-0009
Experimental: Prophylaxis, low dose (once weekly) Drug: 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.
Other Name: NNC-0156-0000-0009
Experimental: On-demand Drug: 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.
Other Name: NNC-0156-0000-0009
Experimental: Prophylaxis, high dose (every second week) Drug: 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 Name: NNC-0156-0000-0009

  Eligibility

Ages Eligible for Study:   13 Years to 70 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previous participation in NN7999-3747 (NCT01333111) and/or NN7999-3773

Exclusion Criteria:

  • Known history of FIX inhibitors based on existing medical records, laboratory report reviews and patient and LAR (legal acceptable representative) interviews
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01395810

  Hide Study Locations
Locations
United States, California
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90027-6016
Novo Nordisk Investigational Site
San Francisco, California, United States, 94143
United States, District of Columbia
Novo Nordisk Investigational Site
Washington, District of Columbia, United States, 20007
United States, Florida
Novo Nordisk Investigational Site
Jacksonville, Florida, United States, 32207
United States, Georgia
Novo Nordisk Investigational Site
Augusta, Georgia, United States, 30912
United States, Iowa
Novo Nordisk Investigational Site
Iowa City, Iowa, United States, 52242
United States, Maryland
Novo Nordisk Investigational Site
Baltimore, Maryland, United States, 21287
United States, Minnesota
Novo Nordisk Investigational Site
Minneapolis, Minnesota, United States, 55404
United States, Nebraska
Novo Nordisk Investigational Site
Omaha, Nebraska, United States, 68198-5456
United States, New Jersey
Novo Nordisk Investigational Site
Newark, New Jersey, United States, 07102
United States, New York
Novo Nordisk Investigational Site
New York, New York, United States, 10029
Novo Nordisk Investigational Site
Syracuse, New York, United States, 13210
United States, Texas
Novo Nordisk Investigational Site
Houston, Texas, United States, 77030
Austria
Novo Nordisk Investigational Site
Wien, Austria, 1090
France
Novo Nordisk Investigational Site
Bron Cedex, France, 69677
Novo Nordisk Investigational Site
Kremlin-Bicêtre, France, 94270
Germany
Novo Nordisk Investigational Site
Bonn, Germany, 53127
Novo Nordisk Investigational Site
Duisburg, Germany, 47051
Novo Nordisk Investigational Site
Giessen, Germany, 35392
Novo Nordisk Investigational Site
Hannover, Germany, 30625
Greece
Novo Nordisk Investigational Site
Athens, Greece, GR-11527
Italy
Novo Nordisk Investigational Site
Firenze, Italy, 50134
Novo Nordisk Investigational Site
Milano, Italy, 20124
Japan
Novo Nordisk Investigational Site
Kashihara-shi, Nara, Japan, 634 8522
Novo Nordisk Investigational Site
Kawasaki-shi, Kanagawa, Japan, 216-8511
Novo Nordisk Investigational Site
Nagoya-shi, Aichi, Japan, 466 8560
Novo Nordisk Investigational Site
Nishinomiya-shi, Japan, 663 8051
Novo Nordisk Investigational Site
Shinjuku-ku, Tokyo, Japan, 160 0023
Novo Nordisk Investigational Site
Suginami-ku, Tokyo, Japan, 1670035
Macedonia, The Former Yugoslav Republic of
Novo Nordisk Investigational Site
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Malaysia
Novo Nordisk Investigational Site
Kuala Lumpur, Malaysia, 50400
Netherlands
Novo Nordisk Investigational Site
Utrecht, Netherlands, 3584 CX
Romania
Novo Nordisk Investigational Site
Timisoara, Timis, Romania, 300011
Russian Federation
Novo Nordisk Investigational Site
Moscow, Russian Federation, 105077
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 191119
South Africa
Novo Nordisk Investigational Site
Parktown Johannesburg, Gauteng, South Africa, 2193
Spain
Novo Nordisk Investigational Site
Madrid, Spain, 28046
Novo Nordisk Investigational Site
Valencia, Spain, 46026
Taiwan
Novo Nordisk Investigational Site
Taipei, Taiwan, 100
Thailand
Novo Nordisk Investigational Site
Bangkok, Thailand, 10400
Turkey
Novo Nordisk Investigational Site
Ankara, Turkey, 06500
Novo Nordisk Investigational Site
Kayseri, Turkey, 38010
Novo Nordisk Investigational Site
Konya, Turkey, 42090
United Kingdom
Novo Nordisk Investigational Site
Basingstoke, United Kingdom, RG24 9NA
Novo Nordisk Investigational Site
Cardiff, United Kingdom, CF14 4XW
Novo Nordisk Investigational Site
London, United Kingdom, NW3 2QG
Novo Nordisk Investigational Site
London, United Kingdom, SE1 7EH
Novo Nordisk Investigational Site
Manchester, United Kingdom, M13 9WL
Novo Nordisk Investigational Site
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01395810     History of Changes
Other Study ID Numbers: NN7999-3775  2010-023072-17  U1111-1121-5408  JapicCTI-121812 
Study First Received: June 30, 2011
Last Updated: November 10, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Italy: AIFA, National Medicines Agency
Japan: Ministry of Health, Labour and Welfare (MHLW)
Macedonia, The Former Yugoslav Republic of: Ministry of Health of Republic of Macedonia
Malaysia: Drug Control Authority (DCA)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
South Africa: Medicines Control Council
Taiwan: Department of Health
Thailand: THFDA
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Germany: Federal Institute for Vaccines and Biomedicines; Paul-Ehrlich-Institut
Greece: National Organization of Medicines

Additional relevant MeSH terms:
Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on December 09, 2016