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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00956345
First received: August 10, 2009
Last updated: July 4, 2012
Last verified: June 2012

August 10, 2009
July 4, 2012
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 ] [ Designated as safety issue: Yes ]
  • Antibody formation against 40K PEG-rFIX and test for inhibitors (Bethesda) [ Time Frame: assessed up to five weeks after trial product administration ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
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 in Non-Bleeding Patients with Haemophilia B.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Congenital Bleeding Disorder
  • Haemophilia B
  • Drug: 40K PEG-rFIX
    Cohort to receive a single dose of 25U/kg 40K PEG-rFIX administered intravenously (into the vein)
  • Drug: 40K PEG-rFIX
    Cohort to receive a single dose of 50U/kg 40K PEG-rFIX administered intravenously (into the vein)
  • Drug: 40K PEG-rFIX
    Cohort to receive a single dose of 100U/kg 40K PEG-rFIX administered intravenously (into the vein)
  • Experimental: A
    Intervention: Drug: 40K PEG-rFIX
  • Experimental: B
    Intervention: Drug: 40K PEG-rFIX
  • Experimental: C
    Intervention: Drug: 40K PEG-rFIX
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. Epub 2011 May 9.

*   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
Male
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Japan,   Spain,   United Kingdom
 
NCT00956345
NN7999-3639, 2009-011085-28, 090857
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Karin Knobe, MD Novo Nordisk A/S
Novo Nordisk A/S
June 2012

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