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

NCT ID: NCT01386528

Last Updated: 2017-08-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-07

Study Completion Date

2013-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Congenital Bleeding Disorder Haemophilia B

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients enrolled in trial

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

Group Type EXPERIMENTAL

nonacog beta pegol

Intervention Type DRUG

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

Interventions

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nonacog beta pegol

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

Intervention Type DRUG

Other Intervention Names

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NNC-0156-0000-0009

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

13 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Los Angeles, California, United States

Site Status

Novo Nordisk Investigational Site

San Francisco, California, United States

Site Status

Novo Nordisk Investigational Site

Washington D.C., District of Columbia, United States

Site Status

Novo Nordisk Investigational Site

Augusta, Georgia, United States

Site Status

Novo Nordisk Investigational Site

Iowa City, Iowa, United States

Site Status

Novo Nordisk Investigational Site

Syracuse, New York, United States

Site Status

Novo Nordisk Investigational Site

Houston, Texas, United States

Site Status

Novo Nordisk Investigational Site

Vienna, , Austria

Site Status

Novo Nordisk Investigational Site

Le Kremlin-Bicêtre, , France

Site Status

Novo Nordisk Investigational Site

Lyon, , France

Site Status

Novo Nordisk Investigational Site

Bonn, , Germany

Site Status

Novo Nordisk Investigational Site

Duisburg, , Germany

Site Status

Novo Nordisk Investigational Site

Giessen, , Germany

Site Status

Novo Nordisk Investigational Site

Hanover, , Germany

Site Status

Novo Nordisk Investigational Site

Athens, , Greece

Site Status

Novo Nordisk Investigational Site

Florence, , Italy

Site Status

Novo Nordisk Investigational Site

Milan, , Italy

Site Status

Novo Nordisk Investigational Site

Kashihara-shi, Nara, , Japan

Site Status

Novo Nordisk Investigational Site

Kawasaki-shi, Kanagawa, , Japan

Site Status

Novo Nordisk Investigational Site

Nagoya-shi, Aichi, , Japan

Site Status

Novo Nordisk Investigational Site

Nishinomiya-shi, , Japan

Site Status

Novo Nordisk Investigational Site

Suginami-ku, Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Kuala Lumpur, , Malaysia

Site Status

Novo Nordisk Investigational Site

Utrecht, , Netherlands

Site Status

Novo Nordisk Investigational Site

Skopje, , North Macedonia

Site Status

Novo Nordisk Investigational Site

Timișoara, Timiș County, Romania

Site Status

Novo Nordisk Investigational Site

Parktown Johannesburg, Gauteng, South Africa

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Valencia, , Spain

Site Status

Novo Nordisk Investigational Site

Taipei, , Taiwan

Site Status

Novo Nordisk Investigational Site

Bangkok, , Thailand

Site Status

Novo Nordisk Investigational Site

Ankara, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Kayseri, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Konya, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Basingstoke, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Cardiff, , United Kingdom

Site Status

Novo Nordisk Investigational Site

London, , United Kingdom

Site Status

Novo Nordisk Investigational Site

London, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Manchester, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Oxford, , United Kingdom

Site Status

Countries

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United States Austria France Germany Greece Italy Japan Malaysia Netherlands North Macedonia Romania South Africa Spain Taiwan Thailand Turkey (Türkiye) United Kingdom

References

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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]

Reference Type BACKGROUND

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2010-023070-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1121-4554

Identifier Type: OTHER

Identifier Source: secondary_id

NN7999-3773

Identifier Type: -

Identifier Source: org_study_id

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