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

Novo Nordisk A/S18 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Congenital Bleeding Disorder Haemophilia B

Interventions

nonacog beta pegolDRUG

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

nonacog beta pegolDRUG

Cohort to receive a single dose of 50U/kg nonacog beta pegol administered intravenously (into the vein)

nonacog beta pegolDRUG

Cohort to receive a single dose of 100U/kg nonacog beta pegol administered intravenously (into the vein)

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (19)

Novo Nordisk Investigational Site

Cincinnati, Ohio, United States

Novo Nordisk Investigational Site

Portland, Oregon, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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