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Evaluating the Haemostatic Effect of NNC 0129-0000-1003 During Surgical Procedures in Subjects With Haemophilia A. (pathfinder™3)

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ClinicalTrials.gov Identifier: NCT01489111
Recruitment Status : Completed
First Posted : December 9, 2011
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted globally. The aim of this trial is to evaluate the haemostatic effect of NNC 0129-0000-1003 during surgical procedures in subjects with haemophilia A.

Condition or disease Intervention/treatment Phase
Congenital Bleeding Disorder Haemophilia A Drug: turoctocog alfa pegol Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of NNC 0129-0000-1003 During Surgical Procedures in Patients With Haemophilia A
Actual Study Start Date : August 3, 2012
Actual Primary Completion Date : December 10, 2018
Actual Study Completion Date : December 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Arm Intervention/treatment
Experimental: Surgery Drug: turoctocog alfa pegol
Bleeding preventive treatment administered i.v. before, during and after surgery. Individually adjusted doses.
Other Name: NNC 0129-0000-1003




Primary Outcome Measures :
  1. Haemostatic effect during surgery evaluated by the four-point scale (excellent, good, moderate or none) [ Time Frame: Assessed by the Investigator/surgeon at the day of surgery ]

Secondary Outcome Measures :
  1. Average consumption of N8-GP [ Time Frame: During surgery ]
  2. Haemostatic effect of N8-GP evaluated by the four-point scale (excellent, good, moderate or none) [ Time Frame: During the post-operative period, days 1-14 ]
  3. Average consumption of N8-GP [ Time Frame: During the post-operative period, days 1-6 ]
  4. Incidence rate of inhibitors against factor VIII (FVIII) (at least 0.6 BU (Bethesda Units)/mL) [ Time Frame: Up to approximately 5 weeks ]


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

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
  • Ongoing participation in the pathfinder™2 (NN7088-3859) or the pathfinderTM 4 (NN7088-3861) trial and having received greater than or equal to 5 doses of N8-GP
  • Undergoing major surgery requiring daily monitoring of FVIII:C (FVIII activity) and wound status for at least 3 days
  • The patient and/or Legally Acceptable Representative (LAR) is capable of assessing a bleeding episode, keeping an eDiary, capable of home treatment of bleeding episodes and otherwise capable of following the trial procedures

Exclusion Criteria:

  • Known or suspected hypersensitivity to trial product including allergy to hamster protein or related products
  • Previous withdrawal from the pathfinder™2 (NN7088-3859) or the pathfinderTM 4 (NN7088-3861) trial after administration of trial product, except interruption due to inclusion in this pathfinderTM 3 trial (NN7088-3860)
  • The receipt of any investigational medicinal product (except N8-GP) within 30 days prior to enrolment into the trial. (For Brazil, only: Participation in a previous clinical trial within one year prior to screening for this trial (Visit 1), unless there is a direct benefit to the research subject, at the Investigator's discretion)
  • FVIII inhibitors at least 0.6 BU (Bethesda Units)/mL at screening
  • 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)
  • Immune modulating or chemotherapeutic medication
  • Any disease (liver, kidney, inflammatory and mental disorders included) or condition which, according to the Investigator's judgement, could imply a potential hazard to the patient, interfere with trial participation or trial outcome
  • Unwillingness, language or other barriers precluding adequate understanding and/or cooperation

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): NCT01489111


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Locations
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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
Novo Nordisk Investigational Site
Sacramento, California, United States, 95817
Novo Nordisk Investigational Site
Torrance, California, United States, 90502-2004
United States, Florida
Novo Nordisk Investigational Site
Orlando, Florida, United States, 32827
Novo Nordisk Investigational Site
Tampa, Florida, United States, 33607
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, New Jersey
Novo Nordisk Investigational Site
Newark, New Jersey, United States, 07102
United States, Ohio
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States, 452289
United States, Oregon
Novo Nordisk Investigational Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
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, 37232-9830
United States, Texas
Novo Nordisk Investigational Site
Houston, Texas, United States, 77030
United States, Virginia
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, 13081-970
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
Le Kremlin Bicetre, 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
Milano, Italy, 20124
Novo Nordisk Investigational Site
Udine, Italy, 33100
Novo Nordisk Investigational Site
Vicenza, Italy, 36100
Japan
Novo Nordisk Investigational Site
Kashihara-shi, Nara, Japan, 634 8522
Novo Nordisk Investigational Site
Shinjuku-ku, Tokyo, Japan, 160 0023
Novo Nordisk Investigational Site
Suginami-ku, Tokyo, Japan, 167 0035
Novo Nordisk Investigational Site
Tokyo, Japan, 108-8639
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
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, S11 8RN
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01489111     History of Changes
Other Study ID Numbers: NN7088-3860
U1111-1119-7326 ( Other Identifier: WHO )
2011-001144-30 ( EudraCT Number )
132215 ( Other Identifier: JapicCTI )
First Posted: December 9, 2011    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019

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