This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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: June 6, 2017
Last verified: June 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
Actual Study Start Date: June 7, 2012
Study Completion Date: December 1, 2013
Primary Completion Date: December 1, 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

  Show 41 Study Locations
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 ( EudraCT Number )
U1111-1121-4554 ( Other Identifier: WHO )
Study First Received: June 30, 2011
Last Updated: June 6, 2017

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

ClinicalTrials.gov processed this record on June 23, 2017