We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Subjects With Haemophilia A (pathfinder™2)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01480180
First Posted: November 28, 2011
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This trial is conducted globally. The aim of the trial is to evaluate the safety and efficacy, including pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in subjects with Haemophilia A.

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-national Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Patients With Haemophilia A

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The Incidence rate of FVIII-inhibitors greater than or equal to 0.6 BU (Bethesda Unit) [ Time Frame: The endpoints will be analysed based on all available information after approximately 24 and 36 months and until the end of trial (EOT) visit ]
  • Annualised bleeding rate in the prophylaxis arm [ Time Frame: The endpoints will be analysed based on all available information after approximately 24 and 36 months and until the end of trial (EOT) visit ]

Secondary Outcome Measures:
  • Haemostatic effect of N8-GP when used for treatment of bleeds, assessed on a four-point scale (excellent, good, moderate and none) [ Time Frame: The endpoints will be analysed based on all available information until the end of trial (EOT) visit and up to approximately 24 and 36 months ]

Enrollment: 186
Actual Study Start Date: January 30, 2012
Estimated Study Completion Date: December 3, 2018
Estimated Primary Completion Date: December 3, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prophylaxis Drug: turoctocog alfa pegol
Administered i.v.
Other Name: NNC 0129-0000-1003
Experimental: On-demand Drug: turoctocog alfa pegol
Administered i.v.
Other Name: NNC 0129-0000-1003

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male patients with severe congenital haemophilia A (FVIII activity below 1%, according to medical records)
  • Documented history of at least 150 EDs (exposure days) to other FVIII products
  • At least 12 years and body weight at least 35 kg (except for Croatia, France, Russia, Israel and the Netherlands where the lower age limit will be 18 years)

Exclusion Criteria:

  • Previous participation in this trial defined as withdrawal after administration N8-GP
  • Any history of FVIII inhibitors
  • FVIII inhibitors above or equal to 0.6 BU/mL at screening
  • HIV (human immunodeficiency virus) positive, defined by medical records with CD4+ (T-lymphocyte subtype) count below or equal to 200/mcL or a viral load of more than 400000 copies/mL. If the data is not available in medical records within last 6 months, CD4+ will be measured at the screening visit
  • Congenital or acquired coagulation disorders other than haemophilia A
  • Previous significant thromboembolic events (e.g. myocardial infarction, cerebrovascular disease or deep venous thrombosis) as defined by available medical records
  • Platelet count below 50,000 platelets/mcL (laboratory value at the screening visit)
  • ALAT (alanine aminotransferase) above 3 times the upper limit of normal reference ranges at central laboratory
  • Creatinine level equal to or greater than 1.5 times above upper normal limit (according to central laboratory reference ranges)
  • Ongoing immune modulating or chemotherapeutic medication
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01480180


  Hide Study Locations
Locations
United States, Arizona
Novo Nordisk Investigational Site
Phoenix, Arizona, United States, 85016
United States, California
Novo Nordisk Investigational Site
Long Beach, California, United States, 90806
Novo Nordisk Investigational Site
Sacramento, California, United States, 95817
Novo Nordisk Investigational Site
Torrance, California, United States, 90502-2004
United States, District of Columbia
Novo Nordisk Investigational Site
Washington, District of Columbia, United States, 20007
Novo Nordisk Investigational Site
Washington, District of Columbia, United States, 20010-2978
United States, Florida
Novo Nordisk Investigational Site
Orlando, Florida, United States, 32827
Novo Nordisk Investigational Site
Tampa, Florida, United States, 33607
United States, Georgia
Novo Nordisk Investigational Site
Augusta, Georgia, United States, 30912
United States, Idaho
Novo Nordisk Investigational Site
Boise, Idaho, United States, 83712
United States, Iowa
Novo Nordisk Investigational Site
Iowa City, Iowa, United States, 52242
United States, Louisiana
Novo Nordisk Investigational Site
New Orleans, Louisiana, United States, 70118-5720
United States, Maryland
Novo Nordisk Investigational Site
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Novo Nordisk Investigational Site
Boston, Massachusetts, United States, 02115
United States, Michigan
Novo Nordisk Investigational Site
Detroit, Michigan, United States, 48201
Novo Nordisk Investigational Site
East Lansing, Michigan, United States, 48823
United States, Minnesota
Novo Nordisk Investigational Site
Minneapolis, Minnesota, United States, 55404
United States, Nebraska
Novo Nordisk Investigational Site
Omaha, Nebraska, United States, 68198-5456
United States, New Jersey
Novo Nordisk Investigational Site
New Brunswick, New Jersey, United States, 08901
Novo Nordisk Investigational Site
Newark, New Jersey, United States, 07102
United States, Ohio
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States, 452289
Novo Nordisk Investigational Site
Dayton, Ohio, United States, 45404
United States, Oregon
Novo Nordisk Investigational Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19134
United States, South Carolina
Novo Nordisk Investigational Site
Charleston, South Carolina, United States, 29425
United States, Tennessee
Novo Nordisk Investigational Site
Nashville, Tennessee, United States, 37232
United States, Texas
Novo Nordisk Investigational Site
Houston, Texas, United States, 77030
United States, Virginia
Novo Nordisk Investigational Site
Charlottesville, Virginia, United States, 22908
Novo Nordisk Investigational Site
Norfolk, Virginia, United States, 23507
United States, Washington
Novo Nordisk Investigational Site
Spokane, Washington, United States, 99204
Australia, New South Wales
Novo Nordisk Investigational Site
Camperdown, New South Wales, Australia, 2050
Australia, Queensland
Novo Nordisk Investigational Site
South Brisbane, Queensland, Australia, 4101
Australia, Victoria
Novo Nordisk Investigational Site
Parkville, Victoria, Australia, 3052
Brazil
Novo Nordisk Investigational Site
Campinas, Sao Paulo, Brazil, 13081970
Bulgaria
Novo Nordisk Investigational Site
Sofia, Bulgaria, 1756
Croatia
Novo Nordisk Investigational Site
Split, Croatia, 21 000
Novo Nordisk Investigational Site
Zagreb, Croatia, 10 000
Denmark
Novo Nordisk Investigational Site
København Ø, Denmark, 2100
Novo Nordisk Investigational Site
Århus N, Denmark, 8200
France
Novo Nordisk Investigational Site
Bron Cedex, France, 69677
Novo Nordisk Investigational Site
Kremlin-Bicêtre, France, 94270
Novo Nordisk Investigational Site
Nantes Cedex 1, France, 44093
Novo Nordisk Investigational Site
Paris, France, 75015
Germany
Novo Nordisk Investigational Site
Berlin, Germany, 10249
Novo Nordisk Investigational Site
Bonn, Germany, 53127
Novo Nordisk Investigational Site
Frankfurt/M., Germany, 60590
Novo Nordisk Investigational Site
Hannover, Germany, 30625
Novo Nordisk Investigational Site
Homburg, Germany, 66421
Novo Nordisk Investigational Site
München, Germany, 80336
Hungary
Novo Nordisk Investigational Site
Budapest, Hungary, H-1134
Novo Nordisk Investigational Site
Debrecen, Hungary, 4012
Israel
Novo Nordisk Investigational Site
Tel-Hashomer, Israel, 52621
Italy
Novo Nordisk Investigational Site
Firenze, Italy, 50134
Novo Nordisk Investigational Site
Milano, Italy, 20124
Novo Nordisk Investigational Site
Udine, Italy, 33100
Novo Nordisk Investigational Site
Vicenza, Italy, 36100
Japan
Novo Nordisk Investigational Site
Hiroshima-shi, Hiroshima, Japan, 734 8551
Novo Nordisk Investigational Site
Kashihara-shi, Nara, Japan, 634 8522
Novo Nordisk Investigational Site
Kitakyusyu, Fukuoka, Japan, 8078555
Novo Nordisk Investigational Site
Nagoya-shi, Aichi, Japan, 466 8560
Novo Nordisk Investigational Site
Saitama, Japan, 350-0225
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
Novo Nordisk Investigational Site
Suginami-ku, Tokyo, Japan, 167 0035
Novo Nordisk Investigational Site
Tokyo, Japan, 108-8639
Novo Nordisk Investigational Site
Yokohama-shi, Kanagawa, Japan, 241-0811
Korea, Republic of
Novo Nordisk Investigational Site
Daejeon, Korea, Republic of, 302-799
Malaysia
Novo Nordisk Investigational Site
Kuala Lumpur, Malaysia, 50400
Novo Nordisk Investigational Site
Selangor Darul Ehsan, Malaysia, 68000
Netherlands
Novo Nordisk Investigational Site
Groningen, Netherlands, 9713 GZ
Novo Nordisk Investigational Site
Rotterdam, Netherlands, 3015 CE
Norway
Novo Nordisk Investigational Site
Oslo, Norway, 0027
Puerto Rico
Novo Nordisk Investigational Site
San Juan, Puerto Rico, 00935
Russian Federation
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 191119
Spain
Novo Nordisk Investigational Site
Madrid, Spain, 28046
Novo Nordisk Investigational Site
Málaga, Spain, 29010
Sweden
Novo Nordisk Investigational Site
Malmö, Sweden, 205 02
Switzerland
Novo Nordisk Investigational Site
Genève 14, Switzerland, 1211
Novo Nordisk Investigational Site
Lausanne, Switzerland, 1011
Novo Nordisk Investigational Site
Zürich, Switzerland, 8091
Taiwan
Novo Nordisk Investigational Site
Changhua, Taiwan, 500
Novo Nordisk Investigational Site
Taipei, Taiwan, 100
Turkey
Novo Nordisk Investigational Site
Adana, Turkey, 01130
Novo Nordisk Investigational Site
Bornova-IZMIR, Turkey, 35100
Novo Nordisk Investigational Site
Samsun, Turkey, 55319
United Kingdom
Novo Nordisk Investigational Site
Basingstoke, United Kingdom, RG24 9NA
Novo Nordisk Investigational Site
Cardiff, United Kingdom, CF14 4XW
Novo Nordisk Investigational Site
London, United Kingdom, NW3 2QG
Novo Nordisk Investigational Site
London, United Kingdom, SE1 7EH
Novo Nordisk Investigational Site
Oxford, United Kingdom, OX3 7LJ
Novo Nordisk Investigational Site
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Giangrande P, Chowdary P, Enhrenforth S, Hanabusa H, Leebeek FW, Lentz SR, Nemes L, Poulsen LH, Santagostino E, You CW, Clausen WHO, Oldenburg J and on behalf of for the pathfinder™2 Investigators. Clinical evaluation of novel recombinant glycopegylated FVIII (turoctocog alfa pegol, N8-GP): efficacy and safety in previously treated patients with severe hemophilia A - results of pathfinder™2 international trial. Journal of Thrombosis and Haemostasis (Abstracts) 2015; 13 (Supplement S2): 1-997 [OR212]

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01480180     History of Changes
Other Study ID Numbers: NN7088-3859
U1111-1119-7416 ( Other Identifier: WHO )
2011-001142-15 ( EudraCT Number )
JapicCTI-121749 ( Other Identifier: Japic )
First Submitted: November 23, 2011
First Posted: November 28, 2011
Last Update Posted: November 8, 2017
Last Verified: November 2017

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