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

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.
 
ClinicalTrials.gov Identifier: NCT00956345
Recruitment Status : Completed
First Posted : August 11, 2009
Last Update Posted : January 20, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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.


Condition or disease Intervention/treatment Phase
Congenital Bleeding Disorder Haemophilia B Drug: nonacog beta pegol Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : August 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 25U/kg 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
Experimental: 50U/kg 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
Experimental: 100U/kg 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Antibody formation against 40K PEG-rFIX and test for inhibitors (Bethesda) [ Time Frame: assessed up to five weeks after trial product administration ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00956345


Locations
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United States, Ohio
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States, 45229
United States, Oregon
Novo Nordisk Investigational Site
Portland, Oregon, United States, 97239
United States, Virginia
Novo Nordisk Investigational Site
Richmond, Virginia, United States, 23219
Denmark
Novo Nordisk Investigational Site
København, Denmark, 2100
France
Novo Nordisk Investigational Site
Kremlin-Bicêtre, France, 94270
Novo Nordisk Investigational Site
Lyon, France, 69003
Germany
Novo Nordisk Investigational Site
Berlin, Germany, 10249
Novo Nordisk Investigational Site
Bonn, Germany, 53127
Novo Nordisk Investigational Site
Frankfurt/M., Germany, 60590
Novo Nordisk Investigational Site
Hannover, Germany, 30625
Japan
Novo Nordisk Investigational Site
Kashihara-shi, Nara, Japan, 634 8522
Novo Nordisk Investigational Site
Nagoya-shi, Aichi, Japan, 466 8560
Novo Nordisk Investigational Site
Nishinomiya-shi, Japan, 663 8051
Spain
Novo Nordisk Investigational Site
Madrid, Spain, 28046
Sweden
Novo Nordisk Investigational Site
Stockholm, Sweden, 171 76
United Kingdom
Novo Nordisk Investigational Site
London, United Kingdom, NW3 2QG
Novo Nordisk Investigational Site
London, United Kingdom, SE1 7EH
Novo Nordisk Investigational Site
Manchester, United Kingdom, M13 9WL
Novo Nordisk Investigational Site
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00956345    
Other Study ID Numbers: NN7999-3639
2009-011085-28 ( EudraCT Number )
090857 ( Registry Identifier: JAPIC )
First Posted: August 11, 2009    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Hemostatic Disorders
Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
 Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Vascular Diseases
Cardiovascular Diseases