NCT01333111|CompletedPhase 3Results

Safety and Efficacy of NNC-0156-0000-0009 in Haemophilia B Patients

paradigm™ 2

A Multi-centre, Single-blind Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC-0156-0000-0009 When Used for Treatment and Prophylaxis of Bleeding Episodes in Patients With Haemophilia B

Novo Nordisk A/S ClinicalTrials.gov

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4 other identifiers

NN7999-37472010-023069-24U1111-1119-6415JapicCTI-111644

Study Type

interventional

Target

Locations

15 countries

Sites

Timeline

RegisteredApr 2011

StartedApr 2011

CompletionMar 2013

Brief Summary

This trial is conducted in Africa, Asia, Europe, Japan and North America. The aim of this trial is to evaluate the safety and efficacy, including pharmacokinetics (the rate at which the body eliminates the trial drug), of NNC-0156-0000-0009 (nonacog beta pegol) when used for treatment and prophylaxis of bleeding episodes in 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 below P25 for phase_3

Timeline

Completed

Started Apr 2011

Geographic Reach

15 countries

43 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

1.9 years study duration

First Submitted

Initial submission to the registry

April 8, 2011

Completed

3 days until next milestone

First Posted

Study publicly available on registry

April 11, 2011

Completed

16 days until next milestone

Study Start

First participant enrolled

April 27, 2011

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2013

Completed

4.3 years until next milestone

Results Posted

Study results publicly available

July 28, 2017

Completed

Last Updated

July 28, 2017

Status Verified

June 1, 2017

Enrollment Period

1.9 years

First QC Date

April 8, 2011

Results QC Date

June 27, 2017

Last Update Submit

June 27, 2017

Conditions

Congenital Bleeding Disorder Haemophilia B

Outcome Measures

Primary Outcomes (2)

Incidence of Inhibitory Antibodies Against Factor IX Defined as Titre Equal to or Above 0.6 BU (Bethesda Units)
Inhibitors were analysed with either the Nijmegen modified factor IX Bethesda assay or a heat/cold Nijmegen modified factor IX Bethesda assay. Number of subjects who developed inhibitory antibodies against factor IX are reported.
52 weeks after treatment start for patients on prophylaxis
Incidence of Inhibitory Antibodies Against Factor IX Defined as Titre Equal to or Above 0.6 BU (Bethesda Units)
Inhibitors were analysed with either the Nijmegen modified factor IX Bethesda assay or a heat/cold Nijmegen modified factor IX Bethesda assay. Number of subjects who developed inhibitory antibodies against factor IX are reported.
28 weeks after treatment start on on-demand treatment

Secondary Outcomes (10)

Haemostatic Effect of NNC-0156-0000-0009 When Used for Prophylaxis of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response
52 weeks after treatment start for patients on prophylaxis
Haemostatic Effect of NNC-0156-0000-0009 When Used for Treatment of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response
28 weeks after treatment start on on-demand treatment
Number of Bleeding Episodes Per Patient During Routine Prophylaxis
52 weeks after treatment start for patients on prophylaxis
Factor IX Trough Levels
52 weeks after treatment start for patients on prophylaxis
Incidence of Adverse Events (AEs)
at 56 weeks ±2 weeks for patients on prophylaxis
+5 more secondary outcomes

Study Arms (3)

Prophylaxis, high dose (trial duration 52 weeks)

EXPERIMENTAL

Drug: nonacog beta pegol

Prophylaxis, low dose (trial duration 52 weeks)

EXPERIMENTAL

Drug: nonacog beta pegol

On-demand (trial duration 28 weeks)

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 (trial duration 52 weeks)

Eligibility Criteria

Age13 Years - 70 Years

Sexmale

Healthy VolunteersNo

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

You may qualify if:

Male patients with moderately severe or severe congenital haemophilia B with a factor IX activity of 2% or below according to medical records
History of at least 150 exposure days to other factor IX products
Patients currently treated on-demand with at least 6 bleeding episodes during the last 12 months or at least 3 bleeding episodes during the last 6 months, or patients currently on prophylaxis

You may not qualify if:

Known history of factor IX inhibitors based on existing medical records, laboratory report reviews and patient and legally acceptable representative (LAR) interviews
HIV (Human immunodeficiency virus) positive, with a viral load equal to or above 400,000 copies/mL and/or CD4+ lymphocyte count equal to or below 200/microL
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)
Immune modulating or chemotherapeutic medication

Contact the study team to confirm eligibility.