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

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ClinicalTrials.gov Identifier: NCT01386528
Recruitment Status : Completed
First Posted : July 1, 2011
Results First Posted : July 24, 2017
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE June 30, 2011
First Posted Date  ICMJE July 1, 2011
Results First Submitted Date  ICMJE June 21, 2017
Results First Posted Date  ICMJE July 24, 2017
Last Update Posted Date August 23, 2017
Actual Study Start Date  ICMJE June 7, 2012
Actual Primary Completion Date December 1, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 30, 2011)
Haemostatic effect during surgery evaluated by the four-point response scale (excellent, good, moderate, poor) [ Time Frame: at the day of surgery ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2011)
  • 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) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Congenital Bleeding Disorder
  • Haemophilia B
Intervention  ICMJE 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
Study Arms  ICMJE 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
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]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2013)
13
Original Estimated Enrollment  ICMJE
 (submitted: June 30, 2011)
12
Actual Study Completion Date  ICMJE December 1, 2013
Actual Primary Completion Date December 1, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 13 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE 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
Removed Location Countries Bulgaria,   Canada,   Hungary,   Russian Federation
 
Administrative Information
NCT Number  ICMJE NCT01386528
Other Study ID Numbers  ICMJE NN7999-3773
2010-023070-40 ( EudraCT Number )
U1111-1121-4554 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date July 2017

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