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NCT01333111 Clinical Trial

Safety and Efficacy of NNC-0156-0000-0009 in Haemophilia B Patients

Congenital Bleeding Disorder Clinical Trial

— paradigm™ 2  

Official title:
A Multi-centre, Single-blind Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC-0156-0000-0009 When Used for Treatment and Prophylaxis of Bleeding Episodes in Patients With Haemophilia B

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01333111
Other study ID # NN7999-3747
Secondary ID 2010-023069-24U1
Status Completed
Phase Phase 3
First received April 8, 2011
Last updated January 19, 2017
Start date April 2011
Est. completion date April 2013

Study information
Verified date January 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, Japan and North America. The aim of this trial is to evaluate the safety and efficacy, including pharmacokinetics (the rate at which the body eliminates the trial drug), of NNC-0156-0000-0009 (nonacog beta pegol) when used for treatment and prophylaxis of bleeding episodes in patients with haemophilia B.

Recruitment information / eligibility
Status Completed
Enrollment 74
Est. completion date April 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Male
Age group 13 Years to 70 Years
Eligibility Inclusion Criteria:

- Male patients with moderately severe or severe congenital haemophilia B with a factor IX activity of 2% or below according to medical records

- History of at least 150 exposure days to other factor IX products

- Patients currently treated on-demand with at least 6 bleeding episodes during the last 12 months or at least 3 bleeding episodes during the last 6 months, or patients currently on prophylaxis

Exclusion Criteria:

- Known history of factor IX inhibitors based on existing medical records, laboratory report reviews and patient and legally acceptable representative (LAR) interviews

- HIV (Human immunodeficiency virus) positive, with a viral load equal to or above 400,000 copies/mL and/or CD4+ lymphocyte count equal to or below 200/microL

- Congenital or acquired coagulation disorders other than haemophilia B

- 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)

- Immune modulating or chemotherapeutic medication

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• nonacog beta pegol
One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience
• nonacog beta pegol
One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience
• nonacog beta pegol
Patients will treat themselves with either a low or a high dose dependent on the severity of the bleeding episode

Locations
Country Name City State
Canada Novo Nordisk Investigational Site Edmonton Alberta
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
Hungary Novo Nordisk Investigational Site Budapest
Italy Novo Nordisk Investigational Site Firenze
Italy Novo Nordisk Investigational Site Milano
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 Shinjuku-ku, Tokyo
Japan Novo Nordisk Investigational Site Suginami-ku, 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
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Saint-Petersburg
South Africa Novo Nordisk Investigational Site Parktown Johannesburg Gauteng
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 Baltimore Maryland
United States Novo Nordisk Investigational Site Hershey Pennsylvania
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site Iowa City Iowa
United States Novo Nordisk Investigational Site Jacksonville Florida
United States Novo Nordisk Investigational Site Los Angeles California
United States Novo Nordisk Investigational Site Minneapolis Minnesota
United States Novo Nordisk Investigational Site New York New York
United States Novo Nordisk Investigational Site Newark New Jersey
United States Novo Nordisk Investigational Site Omaha Nebraska
United States Novo Nordisk Investigational Site Syracuse New York

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

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Hungary,  Italy,  Japan,  Macedonia, The Former Yugoslav Republic of,  Malaysia,  Netherlands,  Russian Federation,  South Africa,  Thailand,  Turkey,  United Kingdom, 

References & Publications (1)

Collins PW, Young G, Knobe K, Karim FA, Angchaisuksiri P, Banner C, Gürsel T, Mahlangu J, Matsushita T, Mauser-Bunschoten EP, Oldenburg J, Walsh CE, Negrier C; paradigm 2 Investigators.. Recombinant long-acting glycoPEGylated factor IX in hemophilia B: a multinational randomized phase 3 trial. Blood. 2014 Dec 18;124(26):3880-6. doi: 10.1182/blood-2014-05-573055. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of inhibitory antibodies against factor IX defined as titre equal to or above 0.6 BU (Bethesda Units) 52 weeks after treatment start for patients on prophylaxis
Primary Incidence of inhibitory antibodies against factor IX defined as titre equal to or above 0.6 BU (Bethesda Units) 28 weeks after treatment start on on-demand treatment
Secondary Haemostatic effect of NNC-0156-0000-0009 when used for prophylaxis of bleeding episodes, assessed as success/failure based on a four-point scale for haemostatic response 52 weeks after treatment start for patients on prophylaxis
Secondary Haemostatic effect of NNC-0156-0000-0009 when used for treatment of bleeding episodes, assessed as success/failure based on a four-point scale for haemostatic response 28 weeks after treatment start on on-demand treatment
Secondary Number of bleeding episodes per patient during routine prophylaxis 52 weeks after treatment start for patients on prophylaxis
Secondary Factor IX trough levels 52 weeks after treatment start for patients on prophylaxis
Secondary Incidence of adverse events (AEs) at 56 weeks ±2 weeks for patients on prophylaxis
Secondary Incidence of adverse events (AEs) at 32 weeks ±2 weeks for patients on on-demand treatment
Secondary Incidence of serious adverse events (SAEs) at 56 weeks ±2 weeks for patients on prophylaxis
Secondary Incidence of serious adverse events (SAEs) at 32 weeks ±2 weeks for patients on on-demand treatment
Secondary Host Cell Proteins (HCP) antibodies 52 weeks after treatment start for patients on prophylaxis
Secondary Host Cell Proteins (HCP) antibodies 28 weeks after treatment start on on-demand treatment
See also
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Completed NCT01949792 - A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors Phase 1
Completed NCT01205724 - Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A Phase 1
Completed NCT01562587 - Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non- Bleeding State Phase 1
Completed NCT00108797 - Trial of NovoSeven® in Haemophilia - Joint Bleeds Phase 4
Completed NCT01493778 - Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A Phase 3
Completed NCT02490787 - Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects Phase 1
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
Completed NCT02920398 - A Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A Phase 1
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 NCT01220141 - Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or B N/A

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