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

Phase 1

Completed

• Conditions: Congenital Bleeding Disorder; Haemophilia B
• Interventions: Drug: nonacog beta pegol

• Registration Number: NCT00956345
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-10
• Study First Submitted QC: 2009-08-10
• Study First Posted: 2009-08-11
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
100U/kg	nonacog beta pegol	-
50U/kg	nonacog beta pegol	-
25U/kg	nonacog beta pegol	-

Primary Outcome Measures

Name	Time	Method
Frequency of Adverse Events (AEs), Serious Adverse Events (SAEs) and Medical Events of Special Interests (MESIs) reported during the trial period	assessed up to five weeks after trial product administration
Antibody formation against 40K PEG-rFIX and test for inhibitors (Bethesda)	assessed up to five weeks after trial product administration

Secondary Outcome Measures

Name	Time	Method
AUC, CL, T½, Incremental recovery (first sample) from 0 to 48 hours 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	assessed up to five weeks after trial product administration

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Oxford, United Kingdom