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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00956345
First Posted: August 11, 2009
Last Update Posted: January 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
August 10, 2009
August 11, 2009
January 20, 2017
August 2009
July 2010   (Final data collection date for primary outcome measure)
  • Frequency of Adverse Events (AEs), Serious Adverse Events (SAEs) and Medical Events of Special Interests (MESIs) reported during the trial period [ Time Frame: assessed up to five weeks after trial product administration ]
  • Antibody formation against 40K PEG-rFIX and test for inhibitors (Bethesda) [ Time Frame: assessed up to five weeks after trial product administration ]
Same as current
Complete list of historical versions of study NCT00956345 on ClinicalTrials.gov Archive Site
  • AUC, CL, T½, Incremental recovery (first sample) from 0 to 48 hours after trial product administration [ Time Frame: assessed up to five weeks after trial product administration ]
  • AUC, CL, T½, Incremental recovery (first sample) from 0 to 168 hours after trial product administration [ Time Frame: assessed up to five weeks after trial product administration ]
Same as current
Not Provided
Not Provided
 
Safety of 40K Pegylated Recombinant Factor IX in Non-Bleeding Patients With Haemophilia B
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.

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Congenital Bleeding Disorder
  • Haemophilia B
  • Drug: nonacog beta pegol
    Cohort to receive a single dose of 25U/kg nonacog beta pegol administered intravenously (into the vein)
    Other Name: 40K PEG-rFIX
  • Drug: nonacog beta pegol
    Cohort to receive a single dose of 50U/kg nonacog beta pegol administered intravenously (into the vein)
    Other Name: 40K PEG-rFIX
  • Drug: nonacog beta pegol
    Cohort to receive a single dose of 100U/kg nonacog beta pegol administered intravenously (into the vein)
    Other Name: 40K PEG-rFIX
  • Experimental: 25U/kg
    Intervention: Drug: nonacog beta pegol
  • Experimental: 50U/kg
    Intervention: Drug: nonacog beta pegol
  • Experimental: 100U/kg
    Intervention: Drug: nonacog beta pegol

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
July 2010
July 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   France,   Germany,   Japan,   Spain,   Sweden,   United Kingdom,   United States
 
 
NCT00956345
NN7999-3639
2009-011085-28 ( EudraCT Number )
090857 ( Registry Identifier: JAPIC )
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP