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.
| Verified date | January 2017 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
United States, Denmark, France, Germany, Japan, Spain, Sweden, United Kingdom,
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
| 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 |
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