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

January 19, 2017 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • København, Denmark, 2100
        • Novo Nordisk Investigational Site
  • France
      • Kremlin-Bicêtre, France, 94270
        • Novo Nordisk Investigational Site
      • Lyon, France, 69003
        • Novo Nordisk Investigational Site
  • Germany
      • 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
        • Novo Nordisk Investigational Site
  • Japan
      • 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
        • Novo Nordisk Investigational Site
  • Spain
      • Madrid, Spain, 28046
        • Novo Nordisk Investigational Site
  • Sweden
      • Stockholm, Sweden, 171 76
        • Novo Nordisk Investigational Site
  • United Kingdom
      • 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
        • Novo Nordisk Investigational Site
  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Novo Nordisk Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Novo Nordisk Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 40K PEG-rFIX
Experimental: 50U/kg
Drug: nonacog beta pegol
Cohort to receive a single dose of 25U/kg nonacog beta pegol administered intravenously (into the vein)
Other Names:
  • 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 Names:
  • 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 Names:
  • 40K PEG-rFIX
Experimental: 100U/kg
Drug: nonacog beta pegol
Cohort to receive a single dose of 25U/kg nonacog beta pegol administered intravenously (into the vein)
Other Names:
  • 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 Names:
  • 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 Names:
  • 40K PEG-rFIX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
assessed up to five weeks after trial product administration

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
assessed up to five weeks after trial product administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

August 10, 2009

First Submitted That Met QC Criteria

August 10, 2009

First Posted (Estimate)

August 11, 2009

Study Record Updates

Last Update Posted (Estimate)

January 20, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN7999-3639
  • 2009-011085-28 (EudraCT Number)
  • 090857 (Registry Identifier: JAPIC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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