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NCT01386528 Clinical Trial

Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B

Congenital Bleeding Disorder Clinical Trial

— paradigm™ 3  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01386528
Other study ID # NN7999-3773
Secondary ID 2010-023070-40U1
Status Completed
Phase Phase 3
First received June 30, 2011
Last updated June 6, 2017
Start date June 7, 2012
Est. completion date December 1, 2013

Study information
Verified date June 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 13
Est. completion date December 1, 2013
Est. primary completion date December 1, 2013
Accepts healthy volunteers No
Gender Male
Age group 13 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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).

Locations
Country Name City State
Austria Novo Nordisk Investigational Site Wien
France Novo Nordisk Investigational Site Kremlin-Bicêtre
France Novo Nordisk Investigational Site Lyon
Germany Novo Nordisk Investigational Site Bonn
Germany Novo Nordisk Investigational Site Duisburg
Germany Novo Nordisk Investigational Site Giessen
Germany Novo Nordisk Investigational Site Hannover
Greece Novo Nordisk Investigational Site Athens
Italy Novo Nordisk Investigational Site Firenze
Italy Novo Nordisk Investigational Site Milano
Japan Novo Nordisk Investigational Site Kashihara-shi, Nara
Japan Novo Nordisk Investigational Site Kawasaki-shi, Kanagawa
Japan Novo Nordisk Investigational Site Nagoya-shi, Aichi
Japan Novo Nordisk Investigational Site Nishinomiya-shi
Japan Novo Nordisk Investigational Site Suginami-ku, Tokyo
Japan Novo Nordisk Investigational Site Tokyo
Macedonia, The Former Yugoslav Republic of Novo Nordisk Investigational Site Skopje
Malaysia Novo Nordisk Investigational Site Kuala Lumpur
Netherlands Novo Nordisk Investigational Site Utrecht
Romania Novo Nordisk Investigational Site Timisoara Timis
South Africa Novo Nordisk Investigational Site Parktown Johannesburg Gauteng
Spain Novo Nordisk Investigational Site Madrid
Spain Novo Nordisk Investigational Site Valencia
Taiwan Novo Nordisk Investigational Site Taipei
Thailand Novo Nordisk Investigational Site Bangkok
Turkey Novo Nordisk Investigational Site Ankara
Turkey Novo Nordisk Investigational Site Kayseri
Turkey Novo Nordisk Investigational Site Konya
United Kingdom Novo Nordisk Investigational Site Basingstoke
United Kingdom Novo Nordisk Investigational Site Cardiff
United Kingdom Novo Nordisk Investigational Site London
United Kingdom Novo Nordisk Investigational Site London
United Kingdom Novo Nordisk Investigational Site Manchester
United Kingdom Novo Nordisk Investigational Site Oxford
United States Novo Nordisk Investigational Site Augusta Georgia
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site Iowa City Iowa
United States Novo Nordisk Investigational Site Los Angeles California
United States Novo Nordisk Investigational Site San Francisco California
United States Novo Nordisk Investigational Site Syracuse New York
United States Novo Nordisk Investigational Site Washington, D.C. District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Austria,  France,  Germany,  Greece,  Italy,  Japan,  Macedonia, The Former Yugoslav Republic of,  Malaysia,  Netherlands,  Romania,  South Africa,  Spain,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

References & Publications (1)

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]

Outcome
Type Measure Description Time frame Safety issue
Primary Haemostatic effect during surgery evaluated by the four-point response scale (excellent, good, moderate, poor) at the day of surgery
Secondary Consumption of NNC-0156-0000-0009 (U/kg body weight) during surgery (the time from knife to skin until last stitch) and post-operative period (day 1 to day 13)
Secondary Transfusion requirements (fulfilling transfusion criteria) during surgery (the time from knife to skin until last stitch) and post-operative period (day 1 to day 13)
Secondary Haemoglobin pre- and post-surgery start 0, 1 hour, 24 hours and every 24 hours in the post-operative period (day 1 to day 13)
Secondary Incidence of Adverse Events (AEs) 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)
Secondary Incidence of Serious Adverse Events (SAE) 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)
Secondary Incidence of inhibitors against FIX (coagulation factor nine) 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)
See also
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Completed NCT00951405 - Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With Inhibitors Phase 2
Completed NCT01876745 - A Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan N/A
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Completed NCT00984126 - Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015 Phase 3
Completed NCT01228669 - Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B Phase 1
Completed NCT01988532 - Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia N/A
Completed NCT01234545 - Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors N/A
Completed NCT01779921 - Treatment of Congenital Factor VII Deficiency N/A
Completed NCT01563471 - Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers Phase 1
Completed NCT02941354 - Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A Phase 1
Completed NCT02241694 - To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives N/A
Completed NCT01230021 - Safety of a Single Intravenous Dose of Recombinant Factor XIII in Children With Congenital FXIII A-subunit Deficiency Phase 3

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