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Completed

NCT Number: NCT00956345

Safety of 40K Pegylated Recombinant Factor IX 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.

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Key information

Conditions

Congenital Bleeding Disorder Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Haemophilia B Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia B Hemorrhagic Disorders

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nonacog beta pegol

Drug

Cohort to receive a single dose of 25U/kg nonacog beta pegol administered intravenously (into the vein)

Other names: 40K PEG-rFIX

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 11, 2009
Registry last updated
Jan 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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