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

July 27, 2020 updated by: Novo Nordisk A/S

Efficacy and Safety of NNC 0129-0000-1003 During Surgical Procedures in Patients With Haemophilia A

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Novo Nordisk Investigational Site
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Novo Nordisk Investigational Site
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Novo Nordisk Investigational Site
  • Brazil
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13081-970
        • Novo Nordisk Investigational Site
  • Bulgaria
      • Sofia, Bulgaria, 1756
        • Novo Nordisk Investigational Site
  • Croatia
      • Split, Croatia, 21 000
        • Novo Nordisk Investigational Site
      • Zagreb, Croatia, 10 000
        • Novo Nordisk Investigational Site
  • Denmark
      • København Ø, Denmark, 2100
        • Novo Nordisk Investigational Site
      • Århus N, Denmark, 8200
        • Novo Nordisk Investigational Site
  • France
      • 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
        • Novo Nordisk Investigational Site
  • Germany
      • 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
        • Novo Nordisk Investigational Site
  • Hungary
      • Budapest, Hungary, H-1134
        • Novo Nordisk Investigational Site
      • Debrecen, Hungary, 4012
        • Novo Nordisk Investigational Site
  • Israel
      • Tel-Hashomer, Israel, 52621
        • Novo Nordisk Investigational Site
  • Italy
      • Milano, Italy, 20124
        • Novo Nordisk Investigational Site
      • Udine, Italy, 33100
        • Novo Nordisk Investigational Site
      • Vicenza, Italy, 36100
        • Novo Nordisk Investigational Site
  • Japan
      • 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
        • Novo Nordisk Investigational Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 50400
        • Novo Nordisk Investigational Site
      • Selangor Darul Ehsan, Malaysia, 68000
        • Novo Nordisk Investigational Site
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Novo Nordisk Investigational Site
      • Rotterdam, Netherlands, 3015 CE
        • Novo Nordisk Investigational Site
  • Norway
      • Oslo, Norway, 0027
        • Novo Nordisk Investigational Site
  • Spain
      • Madrid, Spain, 28046
        • Novo Nordisk Investigational Site
      • Málaga, Spain, 29010
        • Novo Nordisk Investigational Site
  • Sweden
      • Malmö, Sweden, 205 02
        • Novo Nordisk Investigational Site
  • Switzerland
      • Genève 14, Switzerland, 1211
        • Novo Nordisk Investigational Site
      • Lausanne, Switzerland, 1011
        • Novo Nordisk Investigational Site
      • Zürich, Switzerland, 8091
        • Novo Nordisk Investigational Site
  • Taiwan
      • Changhua, Taiwan, 500
        • Novo Nordisk Investigational Site
      • Taipei, Taiwan, 100
        • Novo Nordisk Investigational Site
  • Turkey
      • Adana, Turkey, 01130
        • Novo Nordisk Investigational Site
      • Bornova-IZMIR, Turkey, 35100
        • Novo Nordisk Investigational Site
      • Samsun, Turkey, 55319
        • Novo Nordisk Investigational Site
  • United Kingdom
      • 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
        • Novo Nordisk Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016-7710
        • Novo Nordisk Investigational Site
    • California
      • 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
        • Novo Nordisk Investigational Site
    • Florida
      • Orlando, Florida, United States, 32827
        • Novo Nordisk Investigational Site
      • Tampa, Florida, United States, 33607
        • Novo Nordisk Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83712
        • Novo Nordisk Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Novo Nordisk Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70118-5720
        • Novo Nordisk Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Novo Nordisk Investigational Site
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • Novo Nordisk Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 452289
        • Novo Nordisk Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19134
        • Novo Nordisk Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Novo Nordisk Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232-9830
        • Novo Nordisk Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • Novo Nordisk Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Novo Nordisk Investigational Site
    • Washington
      • Spokane, Washington, United States, 99204
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Surgery
Drug: turoctocog alfa pegol
Bleeding preventive treatment administered i.v. before, during and after surgery. Individually adjusted doses.
Other Names:
  • NNC 0129-0000-1003

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Haemostatic Effect During Surgery Evaluated by the Four-point Scale, Assessed by the Investigator/Surgeon at the Day of Surgery - Four-point Response Scale: Excellent, Good, Moderate or None
Time Frame: Assessed by the Investigator/surgeon at the day of surgery

Haemostatic effect during surgery was evaluated on a four-point response scale as 'none', 'moderate', 'good' and 'excellent'. This was assessed after completion of surgery (defined as "last stitch").

Excellent: Better than expected/predicted in this type of procedure. Good: As expected in this type of procedure. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen.

None: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required.
Assessed by the Investigator/surgeon at the day of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Consumption of N8-GP During Surgery
Time Frame: During surgery, defined as the time from "knife to skin" until "last stitch"
Average consumption of N8-GP, during surgery is presented. The time during surgery is defined from 'knife to skin' until 'last stitch'.
During surgery, defined as the time from "knife to skin" until "last stitch"
Haemostatic Effect of N8-GP During the Post-operative Period Days 1-6
Time Frame: During the post-operative period, days 1-6

Haemostatic effect during post-operative period days 1-6 as evaluated on a four-point response scale as 'none', 'moderate', 'good' and 'excellent'.

Excellent: Better than expected/predicted in this type of procedure. Good: As expected in this type of procedure. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen.

None: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required.
During the post-operative period, days 1-6
Haemostatic Effect of N8-GP During the Post-operative Period Days 7-14
Time Frame: During the post-operative period, days 7-14

Haemostatic effect during post-operative period days 1-6 and days 7-14 was evaluated on a four-point response scale as 'none', 'moderate', 'good' and 'excellent'.

Excellent: Better than expected/predicted in this type of procedure. Good: As expected in this type of procedure. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen.

None: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required.
During the post-operative period, days 7-14
Average Consumption of N8-GP During the Post-operative Period Days 1-6
Time Frame: During the post-operative period, days 1-6
Average consumption of N8-GP during post operative period days 1-6 is presented. Analysis population: Full analysis set included all subjects exposed to the trial drug (N8-GP) and completed surgery.
During the post-operative period, days 1-6
Incidence Rate of Inhibitors Against Factor VIII (FVIII) (≥0.6 BU/mL)
Time Frame: during the trial (2-5 weeks)
Incidence rate of inhibitors is the number of newly developed inhibitors per surgery. Development of FVIII inhibitors was measured by a validated Nijmegen modified Bethesda assay. A positive inhibitor test was defined as ≥0.6 bethesda unit. Number of participants with inhibitors at the end of trial is presented.
during the trial (2-5 weeks)
Estimated Blood Loss During Surgery
Time Frame: During surgery
The mean estimated blood loss following surgery is presented. Estimated blood loss (mL) was evaluated post surgery.
During surgery
Number of Transfusions During the Post-operative Period Days 1-6
Time Frame: Post-operative period, days 1-6
Number of blood product transfusions (transfusion of red blood cells) during the post-surgery period, Days 1-6 is presented.
Post-operative period, days 1-6
Length of Stay in the Hospital
Time Frame: During the trial (2-5 weeks)
Mean number of days stayed at the hospital during the trial.
During the trial (2-5 weeks)
Number of Days in Intensive Care
Time Frame: During the trial (2-5 weeks)
Mean number of days in the intensive care due to surgery during the trial is presented.
During the trial (2-5 weeks)
Adverse Events Reported During the Trial Period
Time Frame: During the trial (2-5 weeks)
Number of adverse event during the trial is presented. This includes events from the first trial related activity after the patient has signed the informed consent and until the end of trial (earliest at day 14).
During the trial (2-5 weeks)
Serious Adverse Events Reported During the Trial Period
Time Frame: During the trial (2-5 weeks)
Number of serious adverse event during the trial is presented. This includes events from the first trial related activity after the patient has signed the informed consent and until the end of trial (earliest at day 14).
During the trial (2-5 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 3, 2012

Primary Completion (ACTUAL)

December 10, 2018

Study Completion (ACTUAL)

December 10, 2018

Study Registration Dates

First Submitted

November 23, 2011

First Submitted That Met QC Criteria

December 7, 2011

First Posted (ESTIMATE)

December 9, 2011

Study Record Updates

Last Update Posted (ACTUAL)

August 10, 2020

Last Update Submitted That Met QC Criteria

July 27, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN7088-3860
  • U1111-1119-7326 (OTHER: WHO)
  • 2011-001144-30 (EUDRACT_NUMBER)
  • 132215 (OTHER: JapicCTI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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