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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:
ClinicalTrials.gov Identifier:
NCT01386528
First Posted: July 1, 2011
Last Update Posted: August 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
June 30, 2011
July 1, 2011
June 21, 2017
July 24, 2017
August 23, 2017
June 7, 2012
December 1, 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 ]

Haemostatic effect during surgery was evaluated immediately after surgery (last stitch) using a fourpoint response scale:

- Four-point response scale: Excellent, good, moderate, poor. The evaluation was done by the surgeon, anaesthesiologist and/or investigator based on experience as follows:

  1. Excellent: Better than expected/predicted in this type of procedure.
  2. Good: As expected in this type of procedure.
  3. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen.
  4. Poor: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required.
Haemostatic Effect During Surgery Evaluated by the Four-point Response Scale (Excellent, Good, Moderate, Poor) [ Time Frame: At the day of surgery ]
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) ]
    Mean consumption of nonacog beta pegol (U/kg) used for treatment per patient before surgery, during surgery (the time from knife to skin until last stitch) and post-operative period.
  • 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) ]
    Mean quantity of transfusion during surgery (the time from knife to skin until last stitch) and the postoperative period (Day 1-13).None of the patients required transfusions beyond Day 6 hence no values presented for days 7-13.
  • Haemoglobin Pre- and Post-surgery Start [ Time Frame: 0, 1 hour, 24 hours. ]
    The mean pre-surgery and post surgery haemoglobin level.
  • 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) ]
    The number of adverse events per patient years of exposure, reported during the trial period. Number is the only available option here, the data presented are rate of AEs.
  • 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) ]
    The number of serious adverse events per patient years of exposure, reported during the trial period. Number is the only available option here, the data presented are rate of AEs.
  • 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) ]
    Number of patients with inhibitory antibodies
  • 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) ]
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 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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Congenital Bleeding Disorder
  • Haemophilia B
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
Experimental: Patients enrolled in trial
New patients will be included as well as transferred patients from Paradigm™ 2 or Paradigm™ 4 trial
Intervention: Drug: nonacog beta pegol
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]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
December 1, 2013
December 1, 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
Sexes Eligible for Study: Male
13 Years to 70 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   France,   Germany,   Greece,   Italy,   Japan,   Macedonia, The Former Yugoslav Republic of,   Malaysia,   Netherlands,   Romania,   South Africa,   Spain,   Taiwan,   Thailand,   Turkey,   United Kingdom,   United States
Bulgaria,   Canada,   Hungary,   Russian Federation
 
NCT01386528
NN7999-3773
2010-023070-40 ( EudraCT Number )
U1111-1121-4554 ( Other Identifier: WHO )
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
July 2017

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