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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT00956345

First received: August 10, 2009

Last updated: July 4, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 10, 2009

Last Updated Date

July 4, 2012

Start Date ^ICMJE

August 2009

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]
Antibody formation against 40K PEG-rFIX and test for inhibitors (Bethesda) [ Time Frame: assessed up to five weeks after trial product administration ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00956345 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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 in Non-Bleeding Patients with Haemophilia B.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Congenital Bleeding Disorder
Haemophilia B

Intervention ^ICMJE

Drug: 40K PEG-rFIX
Cohort to receive a single dose of 25U/kg 40K PEG-rFIX administered intravenously (into the vein)
Drug: 40K PEG-rFIX
Cohort to receive a single dose of 50U/kg 40K PEG-rFIX administered intravenously (into the vein)
Drug: 40K PEG-rFIX
Cohort to receive a single dose of 100U/kg 40K PEG-rFIX administered intravenously (into the vein)

Study Arm (s)

Experimental: A
Intervention: Drug: 40K PEG-rFIX
Experimental: B
Intervention: Drug: 40K PEG-rFIX
Experimental: C
Intervention: Drug: 40K PEG-rFIX

Publications *

Negrier C, Knobe K, Tiede A, Giangrande P, Møss J. Enhanced pharmacokinetic properties of a glycoPEGylated recombinant factor IX: a first human dose trial in patients with hemophilia B. Blood. 2011 Sep 8;118(10):2695-701. Epub 2011 May 9.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2010

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, France, Germany, Japan, Spain, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00956345

Other Study ID Numbers ^ICMJE

NN7999-3639, 2009-011085-28, 090857

Has Data Monitoring Committee

Responsible Party

Novo Nordisk

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Karin Knobe, MD

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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