NCT01386528|CompletedPhase 3Results

Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B

paradigm™ 3

An Open-label, Multi-centre, Un-controlled Trial to Assess Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Patients With Haemophilia B

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN7999-37732010-023070-40U1111-1121-4554

Study Type

interventional

Target

Locations

17 countries

Sites

Timeline

RegisteredJul 2011

StartedJun 2012

CompletionDec 2013

Brief Summary

This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of the trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 (nonacog beta pegol) during surgical procedures 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 Jun 2012

Geographic Reach

17 countries

41 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

1.5 years study duration

First Submitted

Initial submission to the registry

June 30, 2011

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2011

Completed

11 months until next milestone

Study Start

First participant enrolled

June 7, 2012

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed

3.6 years until next milestone

Results Posted

Study results publicly available

July 24, 2017

Completed

Last Updated

August 23, 2017

Status Verified

July 1, 2017

Enrollment Period

1.5 years

First QC Date

June 30, 2011

Results QC Date

June 21, 2017

Last Update Submit

July 24, 2017

Conditions

Congenital Bleeding Disorder Haemophilia B

Outcome Measures

Primary Outcomes (1)

Haemostatic Effect During Surgery Evaluated by the Four-point Response Scale (Excellent, Good, Moderate, Poor)
Haemostatic effect during surgery was evaluated immediately after surgery (last stitch) using a fourpoint response scale: \- Four-point response scale: Excellent, good, moderate, poor. The evaluation was done by the surgeon, anaesthesiologist and/or investigator based on experience as follows: 1. Excellent: Better than expected/predicted in this type of procedure. 2. Good: As expected in this type of procedure. 3. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen. 4. Poor: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required.
At the day of surgery

Secondary Outcomes (6)

Consumption of NNC-0156-0000-0009 (U/kg Body Weight)
During surgery (the time from knife to skin until last stitch) and post-operative period (day 1 to day 13)
Transfusion Requirements (Fulfilling Transfusion Criteria)
during surgery (the time from knife to skin until last stitch) and post-operative period (day 1 to day 13)
Haemoglobin Pre- and Post-surgery Start
0, 1 hour, 24 hours.
Incidence of Adverse Events (AEs)
during the trial period (2-8 weeks prior to day of surgery (transferred subjects) or 2-4 weeks prior to day of surgery (new subjects) until 4 weeks after post-operative period (day 1 to day 13)
Incidence of Serious Adverse Events (SAE)
During the trial period (2-8 weeks prior to day of surgery (transferred subjects) or 2-4 weeks prior to day of surgery (new subjects) until 4 weeks after post-operative period (day 1 to day 13)
+1 more secondary outcomes

Study Arms (1)

Patients enrolled in trial

EXPERIMENTAL

New patients will be included as well as transferred patients from Paradigm™ 2 or Paradigm™ 4 trial

Drug: nonacog beta pegol

Interventions

nonacog beta pegolDRUG

The patients will receive nonacog beta pegol at screening just prior to and during surgical intervention, administered intravenously (into the vein).

Also known as: NNC-0156-0000-0009

Patients enrolled in trial

Eligibility Criteria

Age13 Years - 70 Years

Sexmale

Healthy VolunteersNo

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

You may qualify if:

Patients with haemophilia B with a FIX activity below or equal to 2%
Male patients with moderately severe or severe congenital haemophilia B with a FIX activity below or equal to 2% according to medical records
History of at least 150 exposure days to other FIX products
Scheduled major surgery

You may not qualify if:

Known history of FIX (coagulation factor nine) inhibitors based on existing medical records, laboratory report reviews and patient and LAR (legal acceptable representative) interviews
Current FIX (coagulation factor nine) inhibitors above or equal to 0.6 Bethesda Units (central laboratory)
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)
ALT (alanine aminotransferase) 3 times the upper limit of normal reference ranges at screening (central laboratory)
Immune modulating or chemotherapeutic medication

Contact the study team to confirm eligibility.