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Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B (paradigm™ 3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01386528
First received: June 30, 2011
Last updated: January 19, 2017
Last verified: January 2017
  Purpose

This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of the trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 (nonacog beta pegol) during surgical procedures in patients with haemophilia B.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: An Open-label, Multi-centre, Un-controlled Trial to Assess Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Patients With Haemophilia B

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Haemostatic effect during surgery evaluated by the four-point response scale (excellent, good, moderate, poor) [ Time Frame: at the day of surgery ]

Secondary Outcome Measures:
  • Consumption of NNC-0156-0000-0009 (U/kg body weight) [ Time Frame: during surgery (the time from knife to skin until last stitch) and post-operative period (day 1 to day 13) ]
  • Transfusion requirements (fulfilling transfusion criteria) [ Time Frame: during surgery (the time from knife to skin until last stitch) and post-operative period (day 1 to day 13) ]
  • Haemoglobin pre- and post-surgery start [ Time Frame: 0, 1 hour, 24 hours and every 24 hours in the post-operative period (day 1 to day 13) ]
  • Incidence of Adverse Events (AEs) [ Time Frame: during the trial period (2-8 weeks prior to day of surgery (transferred subjects) or 2-4 weeks prior to day of surgery (new subjects) until 4 weeks after post-operative period (day 1 to day 13) ]
  • Incidence of Serious Adverse Events (SAE) [ Time Frame: during the trial period (2-8 weeks prior to day of surgery (transferred subjects) or 2-4 weeks prior to day of surgery (new subjects) until 4 weeks after post-operative period (day 1 to day 13) ]
  • Incidence of inhibitors against FIX (coagulation factor nine) [ Time Frame: during the trial period (2-8 weeks prior to day of surgery (transferred subjects) or 2-4 weeks prior to day of surgery (new subjects) and every 4 weeks after post-operative period (day 1 to day 13) ]

Enrollment: 13
Study Start Date: June 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients enrolled in trial
New patients will be included as well as transferred patients from Paradigm™ 2 or Paradigm™ 4 trial
Drug: nonacog beta pegol
The patients will receive nonacog beta pegol at screening just prior to and during surgical intervention, administered intravenously (into the vein).
Other Name: NNC-0156-0000-0009

  Eligibility

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

Inclusion Criteria:

  • Patients with haemophilia B with a FIX activity below or equal to 2%
  • Male patients with moderately severe or severe congenital haemophilia B with a FIX activity below or equal to 2% according to medical records
  • History of at least 150 exposure days to other FIX products
  • Scheduled major surgery

Exclusion Criteria:

  • Known history of FIX (coagulation factor nine) inhibitors based on existing medical records, laboratory report reviews and patient and LAR (legal acceptable representative) interviews
  • Current FIX (coagulation factor nine) inhibitors above or equal to 0.6 Bethesda Units (central laboratory)
  • 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)
  • ALT (alanine aminotransferase) 3 times the upper limit of normal reference ranges at screening (central laboratory)
  • Immune modulating or chemotherapeutic medication
  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: NCT01386528

  Hide Study Locations
Locations
United States, California
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90027
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, 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, New York
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
Kremlin-Bicêtre, France, 94270
Novo Nordisk Investigational Site
Lyon, France, 69003
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
Suginami-ku, Tokyo, Japan, 1670035
Novo Nordisk Investigational Site
Tokyo, Japan, 108-8639
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
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:
Publications:
Escobar M, Colberg T, Karim F, Caliskan U, Chowdary P, Giangrande P, Giermasz A, Mancuso ME, Serban M, Tsay W, Zak M and Mahlangu J. Perioperative hemostatic management of major surgery in hemophilia B with long-acting recombinant glycopegylated factor IX: results from the paradigm™3 clinical trial. Journal of Thrombosis and Haemostasis (Abstracts) 2015; 13 (Supplement S2): 1-997 [OR348]

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01386528     History of Changes
Other Study ID Numbers: NN7999-3773  2010-023070-40  U1111-1121-4554 
Study First Received: June 30, 2011
Last Updated: January 19, 2017

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

ClinicalTrials.gov processed this record on February 20, 2017