Clinical trial NCT01386528: Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Congenital Bleeding Disorder
Haemophilia B
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-07-01
Enrollment: 13
Sex: MALE
Minimum age (years): 13
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Haemostatic Effect During Surgery Evaluated by the Four-point Response Scale (Excellent, Good, Moderate, Poor)
timeFrame: At the day of surgery
Secondary outcomes:
measure: Consumption of NNC-0156-0000-0009 (U/kg Body Weight)
timeFrame: During surgery (the time from knife to skin until last stitch) and post-operative period (day 1 to day 13)
measure: Transfusion Requirements (Fulfilling Transfusion Criteria)
timeFrame: during surgery (the time from knife to skin until last stitch) and post-operative period (day 1 to day 13)
measure: Haemoglobin Pre- and Post-surgery Start
timeFrame: 0, 1 hour, 24 hours.
measure: Incidence of Adverse Events (AEs)
timeFrame: 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)
measure: Incidence of Serious Adverse Events (SAE)
timeFrame: 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)
measure: Incidence of Inhibitors Against FIX (Coagulation Factor Nine)
timeFrame: 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)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: San Francisco
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Washington, D.C.
country: United States
facility: Novo Nordisk Investigational Site
state: District of Columbia
city: Augusta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Iowa City
country: United States
facility: Novo Nordisk Investigational Site
state: Iowa
city: Syracuse
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Kremlin-Bicêtre
country: France
facility: Novo Nordisk Investigational Site
city: Lyon
country: France
facility: Novo Nordisk Investigational Site
city: Bonn
country: Germany
facility: Novo Nordisk Investigational Site
city: Duisburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Giessen
country: Germany
facility: Novo Nordisk Investigational Site
city: Hannover
country: Germany
facility: Novo Nordisk Investigational Site
city: Athens
country: Greece
facility: Novo Nordisk Investigational Site
city: Firenze
country: Italy
facility: Novo Nordisk Investigational Site
city: Milano
country: Italy
facility: Novo Nordisk Investigational Site
city: Kashihara-shi, Nara
country: Japan
facility: Novo Nordisk Investigational Site
city: Kawasaki-shi, Kanagawa
country: Japan
facility: Novo Nordisk Investigational Site
city: Nagoya-shi, Aichi
country: Japan
facility: Novo Nordisk Investigational Site
city: Nishinomiya-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Suginami-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: Novo Nordisk Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Utrecht
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Timisoara
country: Romania
facility: Novo Nordisk Investigational Site
state: Timis
city: Parktown Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Valencia
country: Spain
facility: Novo Nordisk Investigational Site
city: Taipei
country: Taiwan
facility: Novo Nordisk Investigational Site
city: Bangkok
country: Thailand
facility: Novo Nordisk Investigational Site
city: Ankara
country: Turkey
facility: Novo Nordisk Investigational Site
city: Kayseri
country: Turkey
facility: Novo Nordisk Investigational Site
city: Konya
country: Turkey
facility: Novo Nordisk Investigational Site
city: Basingstoke
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Cardiff
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Manchester
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Oxford
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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]