NCT00956345|CompletedPhase 1

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

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.

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN7999-36392009-011085-28090857

Study Type

interventional

Target

Locations

8 countries

Sites

Timeline

RegisteredAug 2009

StartedAug 2009

CompletionJul 2010

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_1

Timeline

Completed

Started Aug 2009

Geographic Reach

8 countries

19 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

11 months study duration

Study Start

First participant enrolled

August 1, 2009

Completed

9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2009

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed

Last Updated

January 20, 2017

Status Verified

January 1, 2017

Enrollment Period

11 months

First QC Date

August 10, 2009

Last Update Submit

January 19, 2017

Conditions

Congenital Bleeding Disorder Haemophilia B

Outcome Measures

Primary Outcomes (2)

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 Outcomes (2)

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

Study Arms (3)

25U/kg

EXPERIMENTAL

Drug: nonacog beta pegol

50U/kg

EXPERIMENTAL

Drug: nonacog beta pegol

100U/kg

EXPERIMENTAL

Drug: nonacog beta pegol

Interventions

nonacog beta pegolDRUG

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

Also known as: 40K PEG-rFIX

25U/kg

Eligibility Criteria

Age18 Years - 65 Years

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)

You may not qualify if:

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

Contact the study team to confirm eligibility.