Brief Title
Safety of 40K Pegylated Recombinant Factor IX in Non-Bleeding Patients With Haemophilia B
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.
Brief 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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Frequency of Adverse Events (AEs), Serious Adverse Events (SAEs) and Medical Events of Special Interests (MESIs) reported during the trial period
Secondary Outcome
AUC, CL, T½, Incremental recovery (first sample) from 0 to 48 hours after trial product administration
Condition
Congenital Bleeding Disorder
Intervention
nonacog beta pegol
Study Arms / Comparison Groups
25U/kg
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
18
Start Date
August 2009
Completion Date
July 2010
Primary Completion Date
July 2010
Eligibility Criteria
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
Gender
Male
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Global Clinical Registry (GCR, 1452), ,
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT00956345
Organization ID
NN7999-3639
Secondary IDs
2009-011085-28
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S
Verification Date
January 2017