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: April 22, 2014
Last verified: April 2014

June 30, 2011
April 22, 2014
June 2012
December 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01386528 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Congenital Bleeding Disorder
  • Haemophilia B
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).
Experimental: Patients enrolled in trial
New patients will be included as well as transferred patients from Paradigm™ 2 or Paradigm™ 4 trial
Intervention: Drug: NNC-0156-0000-0009
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Male
13 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Italy,   Japan,   Macedonia, The Former Yugoslav Republic of,   Malaysia,   Netherlands,   Romania,   South Africa,   Spain,   Taiwan,   Thailand,   Turkey,   United Kingdom
 
NCT01386528
NN7999-3773, 2010-023070-40, U1111-1121-4554
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Mona Khan Novo Nordisk A/S
Novo Nordisk A/S
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP