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Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B (paradigm™ 3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01386528
First received: June 30, 2011
Last updated: July 24, 2017
Last verified: July 2017
Results First Received: June 21, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Congenital Bleeding Disorder
Haemophilia B
Intervention: Drug: nonacog beta pegol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 10 sites in 8 countries : Italy (1 site), Malaysia (1 site), Romania (1 site), South Africa (1 site), Taiwan (1 site), Turkey (1 SIte), UK (2 sites), US (2 sites).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients enrolled in the present trial were recruited from the pivotal trial (NN7999-3747) or the extension trial (NN7999-3775). In addition, new patients were recruited into the present trial.

Reporting Groups
  Description
Nonacog Beta Pegol New patients as well as transferred patients from the pivotal trial (NN7999-3747) or the extension trial(NN7999-3775) received nonacog beta pegol at screening and followed a preventive treatment regimen with nonacog beta pegol until one week before the day of surgery. No more than 4 hours prior to the planned surgical procedure, all patients received a single bolus injection of 80 U/kg of nonacog beta pegol. Postoperatively, the patients received fixed doses of 40 U/kg repeated at the investigator’s discretion aiming for no less than the FIX levels recommended by the World Federation of Hemophilia. Nonacog beta pegol was administered intravenously. The new patients were dosed once with 40 U/kg nonacog beta pegol at screening.From the day after surgery (Day 1) and through Day 6, nonacog beta pegol dosing was adjusted to aim for a FIX activity level of approximately 0.50 U/mL.

Participant Flow:   Overall Study
    Nonacog Beta Pegol
STARTED   13 
COMPLETED   13 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The full analysis set consists of all patients exposed to nonacog beta pegol.

Reporting Groups
  Description
Nonacog Beta Pegol New patients as well as transferred patients from the pivotal trial (NN7999-3747) or the extension trial(NN7999-3775) received nonacog beta pegol at screening and followed a preventive treatment regimen with nonacog beta pegol until one week before the day of surgery. No more than 4 hours prior to the planned surgical procedure, all patients received a single bolus injection of 80 U/kg of nonacog beta pegol. Postoperatively, the patients received fixed doses of 40 U/kg repeated at the investigator’s discretion aiming for no less than the FIX levels recommended by the World Federation of Hemophilia. Nonacog beta pegol was administered intravenously. The new patients were dosed once with 40 U/kg nonacog beta pegol at screening.From the day after surgery (Day 1) and through Day 6, nonacog beta pegol dosing was adjusted to aim for a FIX activity level of approximately 0.50 U/mL.

Baseline Measures
   Nonacog Beta Pegol 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      1   7.7% 
Between 18 and 65 years      12  92.3% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Median (Full Range)
 39 
 (15 to 56) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      13 100.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Haemostatic Effect During Surgery Evaluated by the Four-point Response Scale (Excellent, Good, Moderate, Poor)   [ Time Frame: At the day of surgery ]

2.  Secondary:   Consumption of NNC-0156-0000-0009 (U/kg Body Weight)   [ Time Frame: During surgery (the time from knife to skin until last stitch) and post-operative period (day 1 to day 13) ]

3.  Secondary:   Transfusion Requirements (Fulfilling Transfusion Criteria)   [ Time Frame: during surgery (the time from knife to skin until last stitch) and post-operative period (day 1 to day 13) ]

4.  Secondary:   Haemoglobin Pre- and Post-surgery Start   [ Time Frame: 0, 1 hour, 24 hours. ]

5.  Secondary:   Incidence of Adverse Events (AEs)   [ Time Frame: 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) ]

6.  Secondary:   Incidence of Serious Adverse Events (SAE)   [ Time Frame: 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) ]

7.  Secondary:   Incidence of Inhibitors Against FIX (Coagulation Factor Nine)   [ Time Frame: 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) and every 4 weeks after post-operative period (day 1 to day 13) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This is a single armed study having no comparator.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Global Clinical Registry (GCR, 1452)
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com


Publications:
Escobar M, Colberg T, Karim F, Caliskan U, Chowdary P, Giangrande P, Giermasz A, Mancuso ME, Serban M, Tsay W, Zak M and Mahlangu J. Perioperative hemostatic management of major surgery in hemophilia B with long-acting recombinant glycopegylated factor IX: results from the paradigm™3 clinical trial. Journal of Thrombosis and Haemostasis (Abstracts) 2015; 13 (Supplement S2): 1-997 [OR348]


Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01386528     History of Changes
Other Study ID Numbers: NN7999-3773
2010-023070-40 ( EudraCT Number )
U1111-1121-4554 ( Other Identifier: WHO )
Study First Received: June 30, 2011
Results First Received: June 21, 2017
Last Updated: July 24, 2017