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NCT00956345 Clinical Trial

Safety of 40K Pegylated Recombinant Factor IX in Non-Bleeding Patients With Haemophilia B

Congenital Bleeding Disorder Clinical Trial

Official title:
A Multi-Centre, Multi-National, Open-Label, Dose Escalation Trial Evaluating Safety and Pharmacokinetics of Ascending Intravenous Doses of 40K Pegylated Recombinant FIX in Non-Bleeding Patients With Haemophilia B.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00956345
Other study ID # NN7999-3639
Secondary ID 2009-011085-2809
Status Completed
Phase Phase 1
First received August 10, 2009
Last updated January 19, 2017
Start date August 2009
Est. completion date July 2010

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 Europe, Japan and the United States of America (USA).

The aim of this clinical trial is to investigate the safety and pharmacokinetics (the determination of the concentration of the administered medication in blood over time) of Pegylated Recombinant Factor IX (nonacog beta pegol) in Non-Bleeding Patients with Haemophilia B.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Diagnosed with haemophilia B (baseline level of Factor IX less than or equal to 2%)

- History of at least 150 exposure days to any Factor IX products

- Body Mass Index (BMI) below 30.0 kg/m2 (inclusive)

Exclusion Criteria:

- History of Factor IX inhibitors

- Platelet count less than 50,000 platelets/microlitre (assessed by laboratory)

- Kidney or liver dysfunction

- Scheduled surgery requiring Factor IX replacement therapy, during the trial period

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• nonacog beta pegol
Cohort to receive a single dose of 25U/kg nonacog beta pegol administered intravenously (into the vein)
• nonacog beta pegol
Cohort to receive a single dose of 50U/kg nonacog beta pegol administered intravenously (into the vein)
• nonacog beta pegol
Cohort to receive a single dose of 100U/kg nonacog beta pegol administered intravenously (into the vein)

Locations
Country Name City State
Denmark Novo Nordisk Investigational Site København
France Novo Nordisk Investigational Site Kremlin-Bicêtre
France Novo Nordisk Investigational Site Lyon
Germany Novo Nordisk Investigational Site Berlin
Germany Novo Nordisk Investigational Site Bonn
Germany Novo Nordisk Investigational Site Frankfurt/M.
Germany Novo Nordisk Investigational Site Hannover
Japan Novo Nordisk Investigational Site Kashihara-shi, Nara
Japan Novo Nordisk Investigational Site Nagoya-shi, Aichi
Japan Novo Nordisk Investigational Site Nishinomiya-shi
Spain Novo Nordisk Investigational Site Madrid
Sweden Novo Nordisk Investigational Site Stockholm
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 Cincinnati Ohio
United States Novo Nordisk Investigational Site Portland Oregon
United States Novo Nordisk Investigational Site Richmond Virginia

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

Countries where clinical trial is conducted

United States,  Denmark,  France,  Germany,  Japan,  Spain,  Sweden,  United Kingdom, 

References & Publications (2)

Collins PW, Møss J, Knobe K, Groth A, Colberg T, Watson E. Population pharmacokinetic modeling for dose setting of nonacog beta pegol (N9-GP), a glycoPEGylated recombinant factor IX. J Thromb Haemost. 2012 Nov;10(11):2305-12. doi: 10.1111/jth.12000. — View Citation

Negrier C, Knobe K, Tiede A, Giangrande P, Møss J. Enhanced pharmacokinetic properties of a glycoPEGylated recombinant factor IX: a first human dose trial in patients with hemophilia B. Blood. 2011 Sep 8;118(10):2695-701. doi: 10.1182/blood-2011-02-335596. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of Adverse Events (AEs), Serious Adverse Events (SAEs) and Medical Events of Special Interests (MESIs) reported during the trial period assessed up to five weeks after trial product administration
Primary Antibody formation against 40K PEG-rFIX and test for inhibitors (Bethesda) assessed up to five weeks after trial product administration
Secondary AUC, CL, T½, Incremental recovery (first sample) from 0 to 48 hours after trial product administration assessed up to five weeks after trial product administration
Secondary AUC, CL, T½, Incremental recovery (first sample) from 0 to 168 hours after trial product administration assessed up to five weeks after trial product administration
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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