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: April 7, 2014
Last verified: April 2014
  Purpose

This trial is conducted in Asia, Europe, Japan, North America and South Africa. The aim is to evaluate the safety and efficacy of 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: NNC-0156-0000-0009
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: NNC-0156-0000-0009
One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience.
Experimental: Prophylaxis, low dose (once weekly) Drug: NNC-0156-0000-0009
One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience.
Experimental: On-demand Drug: NNC-0156-0000-0009
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.
Experimental: Prophylaxis, high dose (every second week) Drug: NNC-0156-0000-0009
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.

  Eligibility

Ages Eligible for Study:   13 Years to 70 Years
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01395810

  Hide Study Locations
Locations
United States, California
Novo Nordisk Clinical Trial Call Center
Los Angeles, California, United States, 90027-6016
Novo Nordisk Clinical Trial Call Center
San Francisco, California, United States, 94143
United States, District of Columbia
Novo Nordisk Clinical Trial Call Center
Washington, DC, District of Columbia, United States, 20007
United States, Florida
Novo Nordisk Clinical Trial Call Center
Jacksonville, Florida, United States, 32207-8426
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Augusta, Georgia, United States, 30912
United States, Iowa
Novo Nordisk Clinical Trial Call Center
Iowa City, Iowa, United States, 52242
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Baltimore, Maryland, United States, 21287
United States, Minnesota
Novo Nordisk Clinical Trial Call Center
Minneapolis, Minnesota, United States, 55404
United States, Nebraska
Novo Nordisk Clinical Trial Call Center
Omaha, Nebraska, United States, 68198-5456
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Newark, New Jersey, United States, 07102
United States, New York
Novo Nordisk Clinical Trial Call Center
New York, New York, United States, 10029
Novo Nordisk Clinical Trial Call Center
Syracuse, New York, United States, 13210
United States, Texas
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77030
Austria
Wien, Austria, A 1090
France
Bron Cedex, France, 69677
Germany
Bonn, Germany, 53127
Duisburg, Germany, 47051
Hannover, Germany, 30625
Greece
Athens, Greece, GR-11527
Italy
Firenze, Italy, 50134
Milano, Italy, 20124
Japan
Nagoya-shi, Aichi, Japan, 466 8560
Nishinomiya-shi, Japan, 663 8051
Shinjuku-ku, Tokyo, Japan, 160 0023
Suginami-ku, Tokyo, Japan, 1670035
Macedonia, The Former Yugoslav Republic of
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Malaysia
Kuala Lumpur, Malaysia, 50400
Netherlands
Utrecht, Netherlands, 3584 CX
Romania
Timisoara, Timis, Romania, 300011
Russian Federation
Moscow, Russian Federation, 105077
Saint-Petersburg, Russian Federation, 191186
South Africa
Parktown Johannesburg, Gauteng, South Africa, 2193
Spain
Madrid, Spain, 28046
Valencia, Spain, 46026
Taiwan
Taipei, Taiwan, 100
Thailand
Bangkok, Thailand, 10400
Turkey
Ankara, Turkey, 06500
Kayseri, Turkey, 38010
Konya, Turkey, 42090
United Kingdom
Basingstoke, United Kingdom, RG24 9NA
Cardiff, United Kingdom, CF4 4XW
London, United Kingdom, SE1 7EH
London, United Kingdom, NW3 2QG
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:
No publications provided

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: April 7, 2014
Health Authority: Austria: Agency for Health and Food Safety
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Vaccines and Biomedicines; Paul-Ehrlich-Institut
Greece: National Organization of Medicines
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines National Institute of Pharmacy
Italy: AIFA, National Medicines Agency
Japan: Ministry of Health, Labour and Welfare (MHLW)
Malaysia: Drug Control Authority (DCA)
Macedonia, The Former Yugoslav Republic of: Ministry of Health of Republic of Macedonia
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
Spain: Spanish Agency of Medicines and Health Care Products
Taiwan: Department of Health
Thailand: THFDA
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Regulatory Authority (MHRA)
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 21, 2014