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

Purpose

This trial is conducted in Europe, Japan, South Africa and the United States of America (USA). The aim of this trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 during surgical procedures in patients with haemophilia B.

Condition	Intervention	Phase
Congenital Bleeding Disorder Haemophilia B	Drug: NNC-0156-0000-0009	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: Bleeding Disorders

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Haemostatic effect during surgery evaluated by the four-point response scale (excellent, good, moderate, poor) [ Time Frame: at the day of surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
Haemoglobin pre- and post-surgery start [ Time Frame: 0, 1 hour, 24 hours and every 24 hours in the post-operative period (day 1 to day 13) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	June 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Patients enrolled in trial New patients will be included as well as transferred patients from Paradigm™ 2 or Paradigm™ 4 trial	Drug: NNC-0156-0000-0009 The patients will receive NNC-0156-0000-0009 at screening just prior to and during surgical intervention, administered intravenously (into the vein).

Eligibility

Ages Eligible for Study:	13 Years to 70 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01386528

Contacts

Contact: Novo Nordisk

clinicaltrials@novonordisk.com

Hide Study Locations

Locations

United States, California
Novo Nordisk Clinical Trial Call Center	Recruiting
Los Angeles, California, United States, 90027
Novo Nordisk Clinical Trial Call Center	Recruiting
San Francisco, California, United States, 94143
United States, District of Columbia
Novo Nordisk Clinical Trial Call Center	Recruiting
Washington, DC, District of Columbia, United States, 20007
United States, Georgia
Novo Nordisk Clinical Trial Call Center	Recruiting
Augusta, Georgia, United States, 30912
United States, Iowa
Novo Nordisk Clinical Trial Call Center	Recruiting
Iowa City, Iowa, United States, 52242
United States, New York
Novo Nordisk Clinical Trial Call Center	Recruiting
Syracuse, New York, United States, 13210
United States, Texas
Novo Nordisk Clinical Trial Call Center	Recruiting
Houston, Texas, United States, 77030
Austria
	Recruiting
Wien, Austria, A 1090
Bulgaria
	Recruiting
Sofia, Bulgaria, 1756
France
	Recruiting
Lyon, France, 69003
Germany
	Recruiting
Hannover, Germany, 30625
Greece
	Recruiting
Athens, Greece, GR-11527
Italy
	Recruiting
Milano, Italy, 20124
Japan
	Recruiting
Shinjuku-ku, Tokyo, Japan, 160 0023
Macedonia, The Former Yugoslav Republic of
	Recruiting
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Netherlands
	Recruiting
Utrecht, Netherlands, 3584 CX
South Africa
	Recruiting
Parktown Johannesburg, Gauteng, South Africa, 2193
Spain
	Recruiting
Madrid, Spain, 28046
Taiwan
	Recruiting
Taipei, Taiwan, 100
Turkey
	Recruiting
Konya, Turkey, 42090
United Kingdom
	Recruiting
Cardiff, United Kingdom, CF4 4XW
	Recruiting
London, United Kingdom, NW3 2QG

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Mona Khan

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT01386528 History of Changes
Other Study ID Numbers:	NN7999-3773, 2010-023070-40, U1111-1121-4554
Study First Received:	June 30, 2011
Last Updated:	May 3, 2013
Health Authority:	United States: Food and Drug Administration United Kingdom: Medicines And Healthcare Products Regulatory (MHRA) Turkey: Ministry of Health South Africa: Medicines Control Council Japan: Ministry of Health, Labour and Welfare (MHLW) Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Macedonia, The Former Yugoslav Republic of: Ministry of Health of Republic of Macedonia Italy: AIFA, National Medicines Agency Hungary: Ministry of Health, Social and Family Affairs Germany: Federal Institute for Vaccines and Biomedicines; Paul-Ehrlich-Institut France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Canada: Health Canada Taiwan: Department of Health Spain: Spanish Agency of Medicines and Health Care Products Russia: Federal Service for Control of Health Care and Social Development Bulgaria: Ministry of Health Greece: National Organization of Medicines

Additional relevant MeSH terms:

Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemophilia B
Hemophilia A
Hemorrhage
Hematologic Diseases

Vascular Diseases
Cardiovascular Diseases
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013

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