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

This study is currently recruiting participants.
Verified March 2014 by Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
First received: November 23, 2011
Last updated: April 9, 2014
Last verified: March 2014

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 Intervention Phase
Congenital Bleeding Disorder
Haemophilia A
Drug: NNC 0129-0000-1003
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: Efficacy and Safety of NNC 0129-0000-1003 During Surgical Procedures in Patients With Haemophilia A

Resource links provided by NLM:

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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average consumption of N8-GP [ Time Frame: During surgery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Average consumption of N8-GP [ Time Frame: During the post-operative period, days 1-6 ] [ Designated as safety issue: No ]
  • Incidence rate of inhibitors against factor VIII (FVIII) (at least 0.6 BU (Bethesda Units)/mL) [ Time Frame: Up to approximately 5 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: August 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surgery Drug: NNC 0129-0000-1003
Bleeding preventive treatment administered i.v. before, during and after surgery. Individually adjusted doses.


Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489111

Contact: Novo Nordisk clinicaltrials@novonordisk.com

  Show 39 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01489111     History of Changes
Other Study ID Numbers: NN7088-3860, U1111-1119-7326, 2011-001144-30, 132215
Study First Received: November 23, 2011
Last Updated: April 9, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Croatia: Ministry of Health and Social Care
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: BfArM and Paul-Ehrlich Institute (PEI)
Hungary: Ministry of Health, Social and Family Affairs
Italy: AIFA, National Medicines Agency
Japan: Ministry of Health, Labour and Welfare (MHLW)
Malaysia: Drug Control Authority (DCA)
Netherlands: Medicines Evaluation Board, Dutch Health Care Inspectorate
Norway: Norwegian Medicines Control Authority
Spain: Spanish Agency of Medicines and Health Care Products
Switzerland: Federal Office of Public Health
Taiwan: Department of Health, Executive Yuan, R.O.C.
Turkey: Ministry of Health Drug and Pharmaceutical Department
United Kingdom: Medicines and Healthcare Regulatory Authority (MHRA)
United States: Food and Drug Administration

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Hemorrhagic Disorders
Hemophilia A
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Coagulation Protein Disorders
Genetic Diseases, Inborn
Pathologic Processes
Factor VIII
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 20, 2014