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Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00984126
First received: September 21, 2009
Last updated: December 8, 2016
Last verified: December 2016
  Purpose

This trial is conducted in Asia, Europe, Japan, Oceania, North America and South America.

The aim of the trial is to investigate the safety and efficacy of turoctocog alfa (N8) in Haemophilia A patients.

The trial is an extension to trials NN7008-3543 (start: March 2009, stop: September 2011) and NN7008-3545 (start: May 2010, stop: November 2011) and the pharmacokinetic trials NN7008-3600 (start: November 2010, stop: October 2011), NN7008-3893 (start: June 2011, stop: September 2011) and NN7008-4015 (start: August 2012, stop: March 2013).


Condition Intervention Phase
Congenital Bleeding Disorder
Haemophilia A
Drug: turoctocog alfa
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of N8 in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Frequency of development of FVIII inhibitors (greater than or equal to 0.6 Bethesda Units (BU)/mL) [ Time Frame: After 90 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Frequency of Adverse Events (AEs), Serious Adverse Events (SAEs) and Medical Events of Special Interest (MESIs) reported [ Time Frame: After 90 months ] [ Designated as safety issue: Yes ]
  • Average number of bleeds per month reported during the prevention period [ Time Frame: After 90 months ] [ Designated as safety issue: No ]
  • Haemostatic response to turoctocog alfa (none, moderate, good or excellent) in treatment of bleeds. [ Time Frame: After 90 months ] [ Designated as safety issue: No ]

Enrollment: 214
Study Start Date: October 2009
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Turoctocog alfa Drug: turoctocog alfa
The preventative treatment is administered intravenously (i.v.) at specific intervals either every second day or three times a week. Bleeding treatment will be administered if a bleed should occur.
Drug: turoctocog alfa
Treatment is administered intravenously (i.v.) during bleeds and occasionally as a preventative treatment (e.g. before physical activity)

  Eligibility

Ages Eligible for Study:   6 Months to 70 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed Consent obtained before any trial-related activities
  • Completion of trial NN7008-3543 or paediatric trial NN7008-3545 or Japanese trial NN7008-3600 or pharmacokinetic trial NN7008-3893 or NN7008-4015

Exclusion Criteria:

  • Previous participation in the current trial (defined as withdrawal) or withdrawn subjects from NN7008-3522, NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 or NN7008-4015 after administration of trial product
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00984126

  Hide Study Locations
Locations
United States, Arizona
Novo Nordisk Investigational Site
Phoenix, Arizona, United States, 85016-7710
United States, California
Novo Nordisk Investigational Site
Long Beach, California, United States, 90806
United States, Florida
Novo Nordisk Investigational Site
Tampa, Florida, United States, 33607
United States, Georgia
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30322
United States, Iowa
Novo Nordisk Investigational Site
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Novo Nordisk Investigational Site
Boston, Massachusetts, United States, 02115
United States, Ohio
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States, 45229
Novo Nordisk Investigational Site
Dayton, Ohio, United States, 45404
United States, Oregon
Novo Nordisk Investigational Site
Portland, Oregon, United States, 97239
United States, Rhode Island
Novo Nordisk Investigational Site
Providence, Rhode Island, United States, 02903
United States, Tennessee
Novo Nordisk Investigational Site
Nashville, Tennessee, United States, 37232-9830
United States, Texas
Novo Nordisk Investigational Site
Houston, Texas, United States, 77030
United States, Washington
Novo Nordisk Investigational Site
Spokane, Washington, United States, 99204
Brazil
Novo Nordisk Investigational Site
Curitiba, Parana, Brazil, 80250-060
Novo Nordisk Investigational Site
Campinas, Sao Paulo, Brazil, 13081970
Novo Nordisk Investigational Site
São Paulo, Sao Paulo, Brazil, 05403-000
Novo Nordisk Investigational Site
Rio de Janeiro, Brazil, 20211-030
Croatia
Novo Nordisk Investigational Site
Split, Croatia, 21 000
Novo Nordisk Investigational Site
Zagreb, Croatia, 10 000
Germany
Novo Nordisk Investigational Site
Berlin, Germany, 10249
Novo Nordisk Investigational Site
Bonn, Germany, 53127
Novo Nordisk Investigational Site
Giessen, Germany, 35392
Novo Nordisk Investigational Site
Hannover, Germany, 30625
Israel
Novo Nordisk Investigational Site
Tel Aviv, Israel
Novo Nordisk Investigational Site
Tel-Hashomer, Israel, 52621
Italy
Novo Nordisk Investigational Site
Firenze, Italy, 50134
Novo Nordisk Investigational Site
Milano, Italy, 20124
Japan
Novo Nordisk Investigational Site
Kashihara-shi, Nara, Japan, 634 8522
Novo Nordisk Investigational Site
Nagoya-shi, Aichi, Japan, 466 8560
Novo Nordisk Investigational Site
Shimotsuke-shi, Tochigi, Japan, 329 0498
Novo Nordisk Investigational Site
Shinjuku-ku, Tokyo, Japan, 160 0023
Novo Nordisk Investigational Site
Shizuoka-shi, Shizuoka, Japan, 4208660
Latvia
Novo Nordisk Investigational Site
Riga, Latvia, 1006
Lithuania
Novo Nordisk Investigational Site
Vilnius, Lithuania, LT-08406
Macedonia, The Former Yugoslav Republic of
Novo Nordisk Investigational Site
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Malaysia
Novo Nordisk Investigational Site
Kuala Lumpur, Malaysia, 50400
Poland
Novo Nordisk Investigational Site
Warszawa, Poland, 00-576
Novo Nordisk Investigational Site
Wroclaw, Poland, 50-556
Puerto Rico
Novo Nordisk Investigational Site
San Juan, Puerto Rico, 00935
Russian Federation
Novo Nordisk Investigational Site
Moscow, Russian Federation, 119049
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 191119
Serbia
Novo Nordisk Investigational Site
Belgrade, Serbia, 11000
Novo Nordisk Investigational Site
Belgrade, Serbia, 11070
Novo Nordisk Investigational Site
Nis, Serbia, 18000
Novo Nordisk Investigational Site
Novi Sad, Serbia, 21000
Spain
Novo Nordisk Investigational Site
Madrid, Spain, 28046
Novo Nordisk Investigational Site
Valencia, Spain, 46026
Switzerland
Novo Nordisk Investigational Site
Zürich, Switzerland, 8091
Taiwan
Novo Nordisk Investigational Site
Taipei, Taiwan, 100
Turkey
Novo Nordisk Investigational Site
Adana, Turkey, 01130
Novo Nordisk Investigational Site
Antalya, Turkey, 01010
Novo Nordisk Investigational Site
Bornova-IZMIR, Turkey, 35100
Novo Nordisk Investigational Site
Izmit, Turkey, 41380
Novo Nordisk Investigational Site
Samsun, Turkey, 55319
United Kingdom
Novo Nordisk Investigational Site
London, United Kingdom, NW3 2QG
Novo Nordisk Investigational Site
London, United Kingdom, SE1 7EH
Novo Nordisk Investigational Site
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00984126     History of Changes
Other Study ID Numbers: NN7008-3568  2008-005945-46  U1111-1111-9377  JapicCTI-101357 
Study First Received: September 21, 2009
Last Updated: December 8, 2016
Health Authority: Brazil: National Health Surveillance Agency
Croatia: Ministry of Health and Social Care
Germany: Paul-Ehrlich-Institut
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Japan: Ministry of Health, Labor and Welfare
Latvia: Ministry of Health
Lithuania: Lithuanian Bioethics Committee
Macedonia, The Former Yugoslav Republic of: Ministry of Health of Republic of Macedonia
Malaysia: Ministry of Health
Poland: Ministry of Health
Russia: Federal Service for Control of Health Care and Social Development
Serbia: Medicines and Medical Devices Agency of Serbia
Spain: Spanish agency of medicines and health care products
Switzerland: Swissmedic
Taiwan: Department of Health, Executive Yuan, R.O.C.
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Hemophilia A
Hemorrhage
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Factor VIII
Coagulants

ClinicalTrials.gov processed this record on January 14, 2017