Brief Summary

This trial is conducted in Asia, Europe, Japan, North America and South Africa. The aim is to evaluate the safety and efficacy of nonacog beta pegol (NNC-0156-0000-0009) after long-term exposure in patients with haemophilia B. This trial is an extension to trials NN7999-3747 (NCT01333111/paradigm™ 2) and NN7999-3773 (NCT01386528/paradigm™ 3).

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Apr 2012

Geographic Reach

18 countries

49 active sites

Status

completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 years study duration

First Submitted

Initial submission to the registry

June 30, 2011

Completed

18 days until next milestone

First Posted

Study publicly available on registry

July 18, 2011

Completed

9 months until next milestone

Study Start

First participant enrolled

April 15, 2012

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2014

Completed

4.1 years until next milestone

Results Posted

Study results publicly available

May 9, 2018

Completed

Last Updated

May 9, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

June 30, 2011

Results QC Date

November 28, 2017

Last Update Submit

April 9, 2018

Conditions

Congenital Bleeding Disorder Haemophilia B

Outcome Measures

Primary Outcomes (1)

Incidence of Inhibitory Antibodies Against FIX Defined as Titre Above or Equal to 0.6 BU (Bethesda Units)
The primary endpoint was incidence of inhibitors against coagulation factor nine (FIX) defined as titre ≥0.6 Bethesda unit (BU). Number of subjects who developed inhibitors against FIX are reported.
From Day 1 up to 2 years

Secondary Outcomes (5)

Haemostatic Effect of Nonacog Beta Pegol When Used for Treatment of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate, Poor)
From Day 1 up to 2 years
Number of Bleeding Episodes During Routine Prophylaxis
From Day 1 up to 2 years
FIX Trough Levels
From Day 1 up to 2 years
Incidence of Adverse Events (AEs)
From Day 1 up to 2 years
Incidence of Serious Adverse Events (SAEs)
From Day 1 up to 2 years

Study Arms (4)

Prophylaxis, high dose (once weekly)

EXPERIMENTAL

Drug: nonacog beta pegol

Prophylaxis, low dose (once weekly)

EXPERIMENTAL

Drug: nonacog beta pegol

On-demand

EXPERIMENTAL

Drug: nonacog beta pegol

Prophylaxis, high dose (every second week)

EXPERIMENTAL

Drug: nonacog beta pegol

Interventions

nonacog beta pegolDRUG

One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience.

Also known as: NNC-0156-0000-0009

Prophylaxis, high dose (once weekly)Prophylaxis, low dose (once weekly)

Eligibility Criteria

Age13 Years - 70 Years

Sexmale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Previous participation in NN7999-3747 (NCT01333111) and/or NN7999-3773

You may not qualify if:

Known history of FIX inhibitors based on existing medical records, laboratory report reviews and patient and LAR (legal acceptable representative) interviews
Current FIX inhibitors above or equal to 0.6 BU (Bethesda Units)
Congenital or acquired coagulation disorders other than haemophilia B
Previous arterial thrombotic events (e.g. myocardial infarction and intracranial thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by available medical records)
Any disease (liver, kidney, inflammatory and mental disorders included) or condition which, according to the Investigator's (trial physician) judgement, could imply a potential hazard to the patient, interfere with trial participation, or interfere with trial outcome

Contact the study team to confirm eligibility.