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
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01489111
First received: November 23, 2011
Last updated: April 9, 2014
Last verified: March 2014
  Purpose

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489111

Contacts
Contact: Novo Nordisk clinicaltrials@novonordisk.com

  Show 39 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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
Hemorrhagic Disorders
Hemophilia A
Hemorrhage
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Pathologic Processes
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014