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 24, 2014
Last verified: January 2014
  Purpose

This trial is conducted in Europe, Japan, South Africa and the United States of America (USA). The aim of the trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 during surgical procedures in patients with haemophilia B.


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: 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 ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

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: NNC-0156-0000-0009
The patients will receive NNC-0156-0000-0009 at screening just prior to and during surgical intervention, administered intravenously (into the vein).

  Eligibility

Ages Eligible for Study:   13 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01386528

  Show 20 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Mona Khan Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

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 24, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines And Healthcare Products Regulatory (MHRA)
Turkey: Ministry of Health
South Africa: Medicines Control Council
Japan: Ministry of Health, Labour and Welfare (MHLW)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Macedonia, The Former Yugoslav Republic of: Ministry of Health of Republic of Macedonia
Italy: AIFA, National Medicines Agency
Hungary: Ministry of Health, Social and Family Affairs
Germany: Federal Institute for Vaccines and Biomedicines; Paul-Ehrlich-Institut
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Canada: Health Canada
Taiwan: Department of Health
Spain: Spanish Agency of Medicines and Health Care Products
Russia: Federal Service for Control of Health Care and Social Development
Bulgaria: Ministry of Health
Thailand: Khon Kaen University Ethics Committee for Human Research
Greece: National Organization of Medicines

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 17, 2014